c AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment By www.fiercepharma.com Published On :: Fri, 01 May 2020 15:20:40 +0000 AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment. Full Article
c Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal By www.fiercepharma.com Published On :: Fri, 01 May 2020 20:01:17 +0000 Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization. Full Article
c Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support By www.fiercepharma.com Published On :: Sat, 02 May 2020 21:13:54 +0000 Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said. Full Article
c With the world waiting, Roche socks $459M into COVID-19 antibody test production By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:05:01 +0000 Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. Full Article
c Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:09:09 +0000 While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically. Full Article
c Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:22:41 +0000 Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote. Full Article
c Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water By www.fiercepharma.com Published On :: Tue, 05 May 2020 15:21:47 +0000 Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result. Full Article
c AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go By www.fiercepharma.com Published On :: Tue, 05 May 2020 17:50:19 +0000 AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. Full Article
c Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says By www.fiercepharma.com Published On :: Tue, 05 May 2020 19:56:27 +0000 After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. Full Article
c AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes By www.fiercepharma.com Published On :: Wed, 06 May 2020 14:42:58 +0000 AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. Full Article
c Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials By www.fiercepharma.com Published On :: Wed, 06 May 2020 15:25:53 +0000 German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes. Full Article
c Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:38:33 +0000 Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light. Full Article
c Teva generics benefit from COVID-19 bump––but the boom may not last By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:57:22 +0000 With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year. Full Article
c Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:40:24 +0000 The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism. Full Article
c Biogen gears up Swiss manufacturing facility for potential aducanumab rollout By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:51:06 +0000 Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster. Full Article
c Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:53:18 +0000 Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year. Full Article
c GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed By www.fiercepharma.com Published On :: Thu, 07 May 2020 18:11:22 +0000 Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said. Full Article
c FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact By www.fiercepharma.com Published On :: Fri, 08 May 2020 10:10:53 +0000 Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more. Full Article
c Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:40:29 +0000 Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. Full Article
c Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:50:52 +0000 When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. Full Article
c Roche's Kadcyla wins NICE backing in early breast cancer use By www.fiercepharma.com Published On :: Fri, 08 May 2020 14:47:29 +0000 Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting. Full Article
c Gilead hit with Iranian cyberattack for role in COVID-19 response: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:43:17 +0000 Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights. Full Article
c Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:45:56 +0000 Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports. Full Article
c U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths By feeds.reuters.com Published On :: Fri, 08 May 2020 21:46:52 -0400 The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477. Full Article healthNews
c Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI By feeds.reuters.com Published On :: Fri, 08 May 2020 22:09:29 -0400 The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday. Full Article healthNews
c China reports one new coronavirus case, 15 asymptomatic cases By feeds.reuters.com Published On :: Fri, 08 May 2020 23:09:58 -0400 China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday. Full Article healthNews
c FDA commissioner in self-quarantine after exposure to person with COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 00:38:14 -0400 U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday. Full Article healthNews
c Thailand reports four new coronavirus cases, one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 01:23:35 -0400 Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January. Full Article healthNews
c China to reform disease prevention system By feeds.reuters.com Published On :: Sat, 09 May 2020 03:10:46 -0400 China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday. Full Article healthNews
c Singapore reports 753 new coronavirus cases, taking total to 22,460 By feeds.reuters.com Published On :: Sat, 09 May 2020 03:27:35 -0400 Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases. Full Article healthNews
c China approves Novartis' multiple sclerosis treatment Mayzent By feeds.reuters.com Published On :: Sat, 09 May 2020 03:29:42 -0400 Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday. Full Article healthNews
c Russia records more than 10,000 new coronavirus cases in past day By feeds.reuters.com Published On :: Sat, 09 May 2020 04:07:00 -0400 Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676. Full Article healthNews
c Philippines' coronavirus deaths breach 700 By feeds.reuters.com Published On :: Sat, 09 May 2020 04:50:24 -0400 The Philippines' health ministry reported on Saturday that coronavirus deaths have reached more than 700. Full Article healthNews
c Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi By feeds.reuters.com Published On :: Sat, 09 May 2020 05:18:54 -0400 Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100. Full Article healthNews
c Indonesia reports 533 new COVID-19 cases, biggest in a day By feeds.reuters.com Published On :: Sat, 09 May 2020 05:33:43 -0400 Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said. Full Article healthNews
c Malaysia reports 54 new coronavirus cases and one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 05:37:14 -0400 Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589. Full Article healthNews
c Slovakia records no new coronavirus cases for first time since March 10 By feeds.reuters.com Published On :: Sat, 09 May 2020 05:43:33 -0400 Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed. Full Article healthNews
c Tijuana coronavirus death rate soars after hospital outbreaks By feeds.reuters.com Published On :: Sat, 09 May 2020 07:16:27 -0400 The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards. Full Article healthNews
c New York governor says 5-year old died from rare COVID-related complications By feeds.reuters.com Published On :: Sat, 09 May 2020 07:36:14 -0400 A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday. Full Article healthNews
c Portugal's low-income households struggle to survive pandemic By feeds.reuters.com Published On :: Sat, 09 May 2020 08:02:25 -0400 One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday. Full Article healthNews
c Factbox: Latest on the worldwide spread of the coronavirus By feeds.reuters.com Published On :: Sat, 09 May 2020 09:28:30 -0400 More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday. Full Article healthNews
c Half of Spaniards will see lockdown eased from Monday as death toll falls By feeds.reuters.com Published On :: Sat, 09 May 2020 10:11:10 -0400 Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns. Full Article healthNews
c FDA grants emergency use authorization to Quidel for first antigen test for COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 11:01:00 -0400 The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test. Full Article healthNews
c Best of the Best Biotech Book Recommendations By www.biotechduediligence.com Published On :: Fri, 29 Nov 2019 18:00:39 GMT As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...] Full Article Uncategorized
c Biotech Reading List By www.biotechduediligence.com Published On :: Sun, 08 Dec 2019 08:00:00 GMT I Thought Being a Health Care Reporter Would Make Cancer Easier. I Was Wrong.Alexandra Glorioso (Politico Magazine)Meet the pigs that could solve the human organ transplant crisisKaren Weintraub (MIT Technology Review)The Director of the NIH Lays Out His Vision of the Future of Medical ScienceFrancis Collins (Time)In a rural Wisconsin village, the doctor makes house calls — and sees some of the rarest diseases on EarthMark Johnson (Milwaukee Journal Sentinel)‘I just want to live [...] Full Article biotech reading list
c Journal Watch (Holiday 2019) By www.biotechduediligence.com Published On :: Tue, 24 Dec 2019 02:53:11 GMT Closing out another year at BiotechDueDIligence, thank you for following along! Enjoy another round-up of scientific and medical journal articles driving the conversation and newsflow in biotech.There's lots of great #immunology in @sciencemagazine this week! @JSRustenhoven & @jonykipnis (@kipnislab @UVA) author a fascinating Perspective on how immune cells bypass the blood–brain barrier!https://t.co/6QjcNxU0p6 pic.twitter.com/njjnrn9Yej— Seth Thomas Scanlon (@ImmunoEditor) December 20, [...] Full Article journal watch
c Tribute to Michael Becker By www.biotechduediligence.com Published On :: Fri, 10 Jan 2020 02:38:51 GMT The world of biotech suffered a great loss in 2019 with the passing on Michael Becker. Be sure to take in the tributes to Michael from around the Twitterverse. [...] Full Article Uncategorized
c Journal Watch (January 2020) By www.biotechduediligence.com Published On :: Sat, 01 Feb 2020 03:27:26 GMT Important paper out on #Wuhan #nCoV2019 via @biorxivpreprint96% sequence identity to a bat #coronavirus~80% sequence identity to SARS~95% AA sequence identity in 7 conserved replicase domains to SARSuses the same cell entry receptor, ACE2, as SARShttps://t.co/iwaHTsDGJN pic.twitter.com/dGEjBvGx4j— Andy Biotech (@AndyBiotech) January 23, 2020This is major progress in understanding #Parkinsons disease biology!~ #LRRK2 atomic resolution #cryoEM structure~ Switch between active / inactive conforma [...] Full Article journal watch
c Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime By www.justice.gov Published On :: Wed, 21 Jan 2009 11:01:29 EST A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate. Full Article OPA Press Releases
c Puerto Rico Senator Jorge De Castro Font Pleads Guilty to Honest Services Wire Fraud and Conspiracy to Commit Extortion By www.justice.gov Published On :: Wed, 21 Jan 2009 14:18:53 EST Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion. Full Article OPA Press Releases