Pharmalot, Pharmalittle: Odds of an early-stage biotech drug winning approval are slim

first_img @Pharmalot Ed Silverman By Ed Silverman May 26, 2016 Reprints A day after Sanofi stepped up its pursuit of Medivation, Celgene and Gilead Sciences may make their own bids for the drug maker, Bloomberg News reports. So far, Sanofi is the only company to go public with an offer, although Medivation has rebuffed the $9.3 billion bid. A few other drug makers are believed to be interested in Medivation, including Pfizer, Amgen, AstraZeneca, and Novartis.The FDA Office of Prescription Drug Promotion issued just two letters in this year’s first quarter, maintaining last year’s pace, which also marked a record low in annual enforcement, the Eye on FDA blog tells us. “The drop in enforcement naturally raises questions,” blogger Mark Senak writes. “Has industry gotten really really good with compliance? Has OPDP lost interest?”advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. PharmalotPharmalot, Pharmalittle: Odds of an early-stage biotech drug winning approval are slim Alex Hogan/STATcenter_img [email protected] Walgreens agreed to place Theranos blood-testing centers in thousands of its stores without fully validating the technology, because the retailer worried Elizabeth Holmes would balk if it pushed too hard, the Wall Street Journal writes. The relationship fell apart, but the paper suggests the episode is a good case study of what can go wrong when an established company, which craves growth, bets on an unproven startup.Two former Sigma Pharmaceuticals executives were each fined $25,000, but avoided immediate jail time, for falsifying company accounts, according to the Sydney Morning Herald. Former chief executive Elmo de Alwis and his chief financial officer Mark Smith also pleaded guilty to additional charges relating to misleading the company’s auditors and board of directors.Sanofi’s once-a-day shot for diabetes that combines two drugs was recommended by a regulatory panel Wednesday, Bloomberg News tells us. A similar drug from Novo Nordisk also received support from the panel on Tuesday.Deborah Dunsire, who once ran Millennium Pharmaceuticals, is no longer chief executive of Forum Pharmaceuticals, and her departure follows clinical setbacks, Xconomy reports.Eli Lilly and Pfizer plan to seek regulatory approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain, and cancer pain, Reuters says.Astellas Pharma, Daiichi Sankyo, and Takeda will collaborate on a biomarker database taken from healthy patients to compare with those involved in preclinical and clinical research, according to PMLive. About the Author Reprints Good morning, everyone, and how are you today? We are just fine, thank you, and as busy as usual as we stare at the overwhelming to-do list. No doubt, you can relate. So time to fight back with a few cups of stimulation. Our flavor today is Southern Pecan, which was in short supply for a distressing while. And now, on with the show. Here are a few items of interest to help you along. Hope you have a smashing day and, of course, do keep in touch …The overall likelihood that an early-stage biotech drug will get approved is barely 10 percent, according to a new study from the BIO industry trade group. And for all indications, other than cancer, the odds are 12 percent. Of the 14 major disease areas studied, hematology had the best approval odds at 26 percent, while cancer meds have only a 5 percent chance.Joe Papa, the new Valeant Pharmaceuticals chief executive, will receive compensation that is tied to a so-called “vesting accelerator,” TheStreet tells us. The rewards, which were outlined in a regulatory filing, will reflect progress on issues such as government and customer relations and succession planning. The idea is this approach will make a “significant change” in re-establishing the trust of patients and hospitals.advertisement Tags FDAMedivationTheranoslast_img read more

Radio Stations to be established in Five Primary and Junior High Schools

first_img By E. Hartman Reckord, JIS PRO RelatedRadio Stations to be established in Five Primary and Junior High Schools RelatedRadio Stations to be established in Five Primary and Junior High Schools Advertisements FacebookTwitterWhatsAppEmail Primary and junior high school students from five pilot schools, are to be trained to operate school radio stations, which will be established for the creation and dissemination of media content. The initiative is part of the Media Literacy Project of the Broadcasting Commission of Jamaica (BCJ), which is now in its third phase.   Executive Director of the BCJ, Cordel Green, made the disclosure at a recent meeting held at the National Heroes Circle offices of the Ministry of Education to update officials from the Ministry of the achievements under the project. It was also intended to inform them of work to be undertaken in phase III from June 2012 to September 2013. Mr. Green informed that 150 grades seven to nine students will be trained in media operations as a practical component under the project. They will be selected from five schools where low power radio stations will be established. The schools are: Balcombe Drive Primary and Junior High, Calabar Primary and Junior High School in St. Andrew; Granville Primary and Junior High and Flankers Primary and Junior High in St. James and Central Branch All-Age, Kingston. “We are going to establish five radio stations in the selected schools and expand it to include Internet radio,” he informed. “We developed a kind of mentorship programme for the establishment of the school radio station because we want to twin them with existing stations and we are also collaborating with an entity abroad, which is likely to become (a) partner, which is already experimenting with Internet radio stations in Jamaica and that will help us to spread that out very rapidly,” he added. It is projected that at the end of this phase, the Ministry of Education will begin full roll-out of the media literacy curriculum in primary and secondary schools and teachers’ colleges. “When the programme is fully rolled out in schools, children are expected to increase their use of electronic media for learning and self development; be more aware that some content can be harmful; learn how to recognise inappropriate media content; and be equipped to make informed decisions and respond to risky content in the media,” he said. The Media Literacy Project, which targets grades one to nine students, was launched in 2007 with support of the Ministry of Education, the United Nations Educational, Scientific and Cultural Organisation (UNESCO) and the Joint Board of Teacher Education (JBTE). The curriculum is being delivered in the schools by 30 trainee teachers, who were trained in phase II and assessed on their practicum and final project. Giving an overview of the first phase of the project from 2008 to 2010, Mr. Green said that a package of four lessons on videos, each designed for delivery within a 20-minute class, was developed for grades four to six, which was the original focus of the project. He said the videos and other teaching manuals were then tested by the JBTE in 10 primary schools and select teacher training colleges across the island. Based on the feedback, grades one to three were included. Also, attending the meeting at the Ministry were: Assistant Executive Director, BCJ, Karlene Salmon-Johnson; Advisor to the Minister of Education, Craig Perue, Chief Education Officer, Clement Radcliffe, Information and PR Officer, BCJ, Nicole Morrison; Systems Administrator, BCJ, Jelani Crawford, National Literacy Coordinator, Dr. Andre Hill, and Education Officer – Media Services Unit, Allison Hall. Radio Stations to be established in Five Primary and Junior High Schools EducationJune 21, 2012 RelatedRadio Stations to be established in Five Primary and Junior High Schoolslast_img read more

Lucas Hnath’s Dana H., Starring Deirdre O’Connell, Sets Dates for Off-Broadway Bow

first_img Star Files Production dates have been announced for Dana H., a new play by Tony nominee Lucas Hnath, arriving at off-Broadway’s Vineyard Theatre this winter. The previously announced drama, directed by Les Waters and starring Deirdre O’Connell, will begin previews on February 7, 2020 and officially open on February 25.Adapted from interviews conducted by Steve Cosson with Hnath’s mother, the play tells the true story of Dana (played by O’Connell), the former chaplain of a psych ward where she met a charismatic patient, an ex-convict searching for redemption. Dana was held captive in a series of Florida motels for five months.Dana H. will feature scenic design by Andrew Boyce, costume design by Janice Pytel, sound design by Mikhail Fiksel and lighting/supertitle design by Paul Toben.The production will play a limited engagement through March 15, 2020. Deirdre O’Connell Related Shows Dana H.center_img Deirdre O’Connell(Photo: Caitlin McNaney for Show Closed This production ended its run on March 29, 2020 View Commentslast_img read more

a month agoMan Utd boss Solskjaer reveals new Pogba setback

first_imgMan Utd boss Solskjaer reveals new Pogba setbackby Paul Vegasa month agoSend to a friendShare the loveManchester United boss Ole Gunnar Solskjaer admits Paul Pogba is struggling to make Monday’s clash with Arsenal.Pogba aggravated an ankle injury in United’s Carabao Cup draw with League One Rochdale, in which Ole Gunnar Solskjaer’s side scraped through on penalties.“The situation is he finished the game, 90 minutes, which was fantastic, but he got a knock to his ankle which is very swollen,” said Solskjaer.”So it was better not to go there with the team and he’s in a race for Monday. But that’s the way it is.“Luke’s back in training today, so let’s see how he is. He’s getting there so let’s see how he reacts the next couple of days.“He’s been working really hard, so we hope to see him before international break.” About the authorPaul VegasShare the loveHave your saylast_img read more

Mark Dantonio Appeared To Subtweet Jim Harbaugh, Michigan Before Deleting Tweet

first_imgJim Harbaugh and Mark Dantonio shaking hands after a game.EAST LANSING, MI – OCTOBER 29: Head coach Jim Harbaugh Michigan Wolverines shakes hands with head coach Mark Dantonio of the Michigan State Spartans after a 32-23 Michigan win at Spartan Stadium on October 29, 2016 in East Lansing, Michigan. (Photo by Gregory Shamus/Getty Images)Earlier tonight, Michigan lost a commitment from three-star defensive lineman Rashad Weaver. Weaver claimed the Wolverines staff stopped reaching out to him, and that head coach Jim Harbaugh had told him that there was only a 50/50 chance he’d have a scholarship for him on National Signing Day next week. Shortly after the Weaver news began circulating, Michigan State head coach Mark Dantonio dropped a somewhat-cryptic tweet consisting only of the phrase “The righteous shall prevail.” This would appear to be a not-so-veiled reference to the Michigan situation, and Dantonio quickly deleted the tweet. But, Twitter being Twitter, you know someone got a screen shot of it before it disappeared.Lol mark dantonio quickly deleted this but I think we all know what he was referencing— D2 (@ddycio) January 26, 2016 To add to the intrigue, Michigan State recruiting coordinator Curtis Blackwell tweeted the exact same thing.The righteous shall prevail….— Curtis Blackwell II (@MSUrecruiter) January 26, 2016Seems pretty clear what the intent was here. There is never a dull moment in college football recruiting, that’s for sure.[ Maize ‘N’ Brew ]last_img read more

MUMBAI Punjab and Maharashtra Cooperative PMC

first_imgMUMBAI: Punjab and Maharashtra Co-operative (PMC) Bank used more than 21,000 fictitious accounts to hide loans it made, according to a police complaint lodged by Indian officials, in the latest banking fraud case to spook the country’s depositors and investors. The complaint, filed with the Economic Offences Wing (EOW) of Mumbai Police on Monday and later seen by Reuters, accuses the bank’s management of concealing non-performing assets and disbursing loans leading to a loss of at least Rs 4,355 crore ($616.5 million). Also Read – Commercial vehicle sales to remain subdued in current fiscal: IcraA single realty firm and its group companies were the beneficiaries of 44 loans, according to the complaint. “The actual financial position of the bank was camouflaged, & the bank deceptively reflected a rosy picture of its financial parameters,” said the complaint, noting that the fictitious loan accounts were not entered into the bank’s core banking system – a factor key in the perpetration of a $2 billion fraud at Punjab National Bank that was uncovered in 2018. Also Read – Ashok Leyland stock tanks over 5 pc as co plans to suspend production for up to 15 daysThe complaint names the bank’s chairman Waryam Singh and its managing director Joy Thomas, along with other bank officials, and accuses them of criminal breach of trust, forgery and falsification of records. It also names bankrupt realty company Housing Development and Infrastructure Ltd, along with its former senior executives Sarang Wadhwan and Rakesh Wadhwan, who were beneficiaries of the loans. A senior government official late on Tuesday said that the serious fraud investigation office will look into the alleged wrong doing by HDIL in the PMC case, expecting to complete the investigation in the next two months. PMC Bank and HDIL did not immediately respond to requests for comment. The Reserve Bank of India (RBI) said it had no comment. The PMC case has sparked renewed concerns about the health of India’s troubled banking sector, which has been rocked by a multi-billion dollar fraud at a state-run lender, the collapse of a major infrastructure lender, bad loan issues at state-run banks and a liquidity squeeze that has hit shadow lenders. More than two dozen co-operative banks are now under RBI administration, but PMC Bank – with deposits of Rs 11,620 crore as of March 31 – is by far the largest. The RBI last week moved to take charge of PMC Bank, one of India’s top five co-operative lenders with more than 9,00,000 depositors, and suspended Thomas and the bank’s board after uncovering lending irregularities The RBI has barred the bank from renewing or granting any loans or making investments without prior approval of the central bank, while depositors have been informed they can only withdraw a maximum of Rs 10,000 ($140) from their PMC accounts over the next six months. Dozens of account holders gathered outside an RBI office in Mumbai on Tuesday to protest against the curbs and demand that the central bank and government intervene to release their funds. In a letter written by Thomas to the RBI that allegedly blew the lid off the scam, he says that he oversaw the fraud and hid details from the regulator for fear of reputational risks to the bank. Reuters reviewed a copy of the letter. The police complaint against PMC and HDIL officials was filed at the behest of an administrator, whom the RBI appointed last week to oversee the bank’s operations. The complaint alleges that the PMC officials misled the RBI for over a decade from 2008 to August 2019 by failing to disclose big accounts that had become non-performing assets by producing forged audit reports. It was reported on Sunday that PMC Bank’s exposure to bankrupt HDIL stood at Rs 6,500 crore, which accounts for 73 per cent of its overall Rs 8,880 crore loan book – well above the RBI’s permissible exposure levels to a single entity.last_img read more

India can win big from inevitable 350550bn exports moving out of China

first_imgNew York: India could potentially be one of the big winners from the US-China trade war, according to a Credit Suisse survey of 100 companies with global sales of $1 trillion that projects $350-550 billion of exports will shift out of China and that this is “inevitable even if slow”. This survey insights land at the same time when US Commerce Secretary Wilbur Ross is saying in New Delhi that India has a “wonderful opportunity right now, to take advantage of trade dissension elsewhere”. Also Read – Commercial vehicle sales to remain subdued in current fiscal: Icra $1 billion translates to approximately Rs 7,000 crore. “We’ve actually prepared a chart about what are the areas where China is the big exporter to us? How does that compare with what India is exporting to us? And what are possible solutions to how do we change that mixture?” Ross said at the India Today ‘India Economic Summit’ event in New Delhi on Thursday. The Credit Suisse report, reviewed by IANS, has said that firms in China plan to move production to Vietnam, India, Taiwan and Mexico. Also Read – Ashok Leyland stock tanks over 5 pc as co plans to suspend production for up to 15 days Ross’ comments and the Credit Suisse report both come as China’s top trade negotiator prepares to lead an upcoming 13th round of talks aimed at resolving the ongoing trade war with the US. Chinese Vice Premier Liu He will travel to Washington for the negotiations and trade talks would take place after China’s National Day holiday which falls on October 7. The Credit Suisse report lists three main themes that inform the $350-550 billion “shift”. Peak pressure begins only now Multiple pressures to move manufacturing out of China are likely to peak now because “80 per cent of the finished goods sold to consumers come under tariffs only now”. The report connects the dots to similar goods in earlier lists which saw price rise, lower demand and a shift in production. Companies keen to move out Companies that have spoken to Credit Suisse have said “they would shift manufacturing out of China even without tariffs”. They list a “shrinking Chinese workforce” as one of the main issues: “50 million fewer workers by 2030”. Firms plan to move production to Vietnam, India, Taiwan and Mexico, says the report. Shrinking workforce “In five years though, with the Chinese manufacturing workforce shrinking by another 9-15 million after a 20 million decline since 2015, we expect $350-550 billion of exports to move out of China. It could be more, if other countries improve absorption capacity: Vietnam is too small (but should gain the most), Bangladesh a pure-play on apparel, and India has seen good import substitution in electronics but is struggling to grow apparel exports. Hon Hai and Pegatron would be negatively affected, L&T, Havells and Feng Tay would benefit. In the near- term, tariffs would raise prices in the US (13 per cent of firms absorbing them), and shift Chinese exports to other countries (possibly at lower prices).” US President Donald Trump’s administration first imposed tariffs on Chinese imports in 2018 in a bid to win concessions from China, which responded with tit-for-tat tariffs. A deal remains elusive as the dispute escalates between the world’s two largest economies. In New Delhi, Ross spoke about the “third kind of barrier” that “bothers” the US, which he said was neither about competitive advantage nor one country actually needing a certain product because of locational constraints. “If you look at our trade deficit it has two components, one’s called automotive and the other’s called China,” he said. During his comments, Ross made the distinction between “small trade deficits with other countries” and “China” as two separate issues. “We believe that most of the things we’re requesting particularly of India would not only help us vis a vis India, we think a lot of them would help India itself,” he added. “So, (I) don’t want you to think that we’re just focusing on deficit, we’re focusing also on total trade. And what the world needs is more total trade. This recent diminution in the forecast, that world trade will be down to 1.2 per cent this year, is a very bad omen for the world because normally, trade, global trade has been growing at a percentage point or so. So if it’s really true, that world trade will only grow at around 1 per cent. That does not speak very well for the world GDP. So that’s a source of separate concern,” Ross said.last_img read more

MRPL operations back to normalcy Official

first_imgMangaluru: The problems faced by Mangalore Refinery and Petrochemicals Limited (MRPL) by way of ground soil erosion following heavy rains in August this year have been resolved and all operations were now smooth, company managing director M Venkatesh said on Saturday. Addressing reporters here, he said the MRPL refinery complex had faced the soil erosion due to the intense rainfall during the first and second week of August, affecting the foundation of one of the pipe racks in phase 3. Also Read – Commercial vehicle sales to remain subdued in current fiscal: IcraAn immediate shutdown of the entire phase 3 complex was done as safety measure during the third week of August. All emergency measures were taken on warfooting to arrest any significant damage to pipe racks. After ensuring the safety of the pipe rack through rectification work, the phase 3 refinery complex was commissioned again during the second week of September. He said the entire refinery complex was running normally at peak capacities since then. Also Read – Ashok Leyland stock tanks over 5 pc as co plans to suspend production for up to 15 daysThe crude oil supplies to MRPL were not affected due to recent attack on Saudi oil facilities and the operations were sustained normally. Venkatesh said MRPL has been contributing to the social development of the region through its unstinting efforts under its corporate social responsibility (CSR) initiatives. Our maximum focus is towards Dakshina Kannada and Udupi district. Our CSR spending is over Rs 50 crore for 2019-20,” he said.last_img read more

India win first Test against South Africa by 203 runs

first_imgVisakhapatnam: India dismissed South Africa for 191 runs in their second innings on the fifth and final day to win the opening Test by 203 runs here on Sunday. Defending a 395-run target, India rode on bowling exploits of Ravindra Jadeja and Mohammed Shami to complete the win and help the team take a 1-0 lead in the three-Test series. Shami took five wickets and Jadeja scalped four, while Ravichandran Ashwin took one to equal Sri Lankan great Muttiah Muralitharan in becoming the joint fastest to take 350 wickets. Also Read – India gets first tranche of Swiss account details under automatic exchange framework Resuming at 11 for one, South Africa were reduced to 117 for 8 at lunch. In the post-lunch session, the Proteas lost the remaining two wickets, bundld out for 191 in 63.5 overs. On Saturday, India declared their second innings at 323-4 in 67 overs to set an improbable 395-run target for South Africa. South Africa were 11-1 at stumps on day four. Earlier, the Proteas were bowled out for 431 in their first innings in reply to India’s 502 for seven declared. Brief score: India: 502/7 decl & 323/4 decl (Rohit Sharma 127, Cheteshwar Pujara 81, Ravindra Jadeja 40, Virat Kohli 31 no, Ajinkya Rahane 27 no, Keshav Maharaj 2/129) South Africa: 431 and (target 395) 191 allout in 63.5 overs (D Piedt 56, S Muthusamy 49; Mohammed Shami 5/35, Ravindra Jadeja 4/51).last_img read more

15member NC delegation meets Farooq Omar Abdullah

first_imgSrinagar: In the first major political development post withdrawal of special status to Jammu and Kashmir, a 15-member National Conference delegation on Sunday met detained party leaders Farooq Abdullah and Omar Abdullah here. The delegation discussed developments in the state and upcoming local body polls during the separate meetings with the two leaders. The Jammu and Kashmir government had given permission to the delegation to meet the leaders. Also Read – India gets first tranche of Swiss account details under automatic exchange framework The delegation led by Jammu’s provincial chief of the party Davinder Singh Rana met former chief Minister Omar Abdullah at Hari Nivas for little over 30 minutes. This was the first meeting of Omar with a party delegation after he was detained on August 5, a day when the Centre announced abrogation of special status to the state under Article 370. Omar, who was sporting a beard, was seen clicking a selfie with party leaders. The delegation then drove to Farooq Abdullah’s residence. Also Read – Afghan Taliban frees 3 Indian hostages in exchange for 11 top militant leaders: Reports Emerging after the meeting, Rana told reporters that for any political process to begin, the leaders of the party need to be released. There is “anguish about developments particularly about lockdown of the people and we, as a party, appeal that the political process to start and democracy to revive in Jammu and Kashmir political detenues anywhere and everywhere, whether from mainstream political parties or otherwise who have no criminal record, may be released to initiate the process and the hearts and minds of the people of Jammu and Kashmir are won,” he said. He said the party, which has a legacy, history and a chequered track record, was of unanimous view that it would continue to strive for the welfare of the people and shall continue to work for communal harmony, brotherhood, togetherness and keep the secular fabric of the state shining. On a question about the party’s participation in block development committee elections, he said, “See there is a complete lockdown. If the political process has to start then these members have to be released. Rana said,”After restrictions on political leaders in Jammu were removed, we held a meeting in which it was decided that we will approach governor (S P Malik) to seek his permission to have an audience with the president and the vice president of the party”. We are happy they are both well and in high spirits. Of course, they are pained and anguished about developments, particularly lockdown of the people,” he said. Asked about the party’s stand on the upcoming Block Development Council (BDC) elections, Rana said for any political process to start in the state, the mainstream political leaders should be released first. In case of NC, even if we want to contest the BDC elections, the 380 panchayats that exist, the mandate has to be signed by the party president who has been unfortunately detained under the PSA, he said. The NC leader said the party’s working committee would decide on the future course of action whenever the party leaders including the NC president and vice-president would be released. Let them be released, then the working committee of the party will meet and discuss and then we will formulate a strategy for the future, Rana said when questioned about the party’s future strategy.last_img read more

Developers expect slight demand uptick in festival season

first_imgNew Delhi: Real estate developers have largely witnessed subdued demand and low absorption of residential properties in the past few years, but with the latest reduction in the RBI repo rate and few banks launching repo rate-linked home loans, market players feel that the traditional festival demand would witness a slight uptick this year. The Reserve Bank of India’s (RBI) Governor Shaktikanta Das on Friday announced a 25 basis points (bps) cut in the repo, or short-term lending rate for commercial banks, to 5.15 per cent. Also Read – Commercial vehicle sales to remain subdued in current fiscal: Icra”The RBI decision to further reduce the repo rate by 25 basis points to bring it to 5.15 per cent gives the real estate sector a reason to cheer at a time when it expects sales to improve in the ongoing festive season,” said Dhruv Agarwala, Group CEO, Elara Technologies. Acoording to Rajat Goel, Joint Managing Director, MRG World, the repo rate cut is in sync with the government’s recent measures, including a reduction in the corporate tax, to promote credit offtake in order to boost economic activity during the festive season amid the ongoing slowdown. Also Read – Ashok Leyland stock tanks over 5 pc as co plans to suspend production for up to 15 daysAlthough the monetary policy committee (MPC) has decided to go for rate cuts in its last five successive bi-monthly meets, the transmission of these reductions to retail loans have been slow and not in proportion to the repo rate cuts, which remains a cause of concern for retail borrowers. One of the positive factors has been that banks have started to come up with repo-rate linked home loans. Moreover, there have been a slew of measures announced recently to support the sector, including capital support for housing finance companies and creation of a Rs 20,000 crore corpus with half the investment coming from the government. Market players are of the view that the rate cuts along with these measures should aid the ailing sector. Prashin Jhobalia, Vice President for Marketing Strategy at House of Hiranandani, says that festive occasions still govern the buyers’ psyche across the country with several property seekers advancing or postponing their purchase decisions to coincide with the festivals. “Potential home-buyers associate the festive season with security and prosperity, making them sanguine about lucrative offers available in the real estate market through this period,” Jhobalia said.last_img read more