b Global pharma and biotech’s fight against COVID-19: an investment perspective By www.thepharmaletter.com Published On :: Wed, 06 May 2020 18:01:00 +0100 Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives… Full Article Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK
b Checkpoint blocker plus chemo shows impact in lung cancer By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:30:00 +0100 A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,… Full Article Biotechnology/China/Drug Trial/Eli Lilly & Company/Gemzar/Immuno-oncology/Innovent Biologics/Research/Tyvyt/USA
b BRIEF—GSK completes sale of nutrition brands for £3.4 billion By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:44:00 +0100 GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products… Full Article Companies mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK
b First targeted therapy for aggressive form of lung cancer approved by FDA By www.thepharmaletter.com Published On :: Thu, 07 May 2020 11:10:00 +0100 Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta… Full Article Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA
b Mediolanum buys French I-O company By www.thepharmaletter.com Published On :: Thu, 07 May 2020 15:33:00 +0100 Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist… Full Article Biotechnology/Companies mergers and acquisitions/Elsalys Biotech/France/Immuno-oncology/Italy/Leukotac/Mediolanum/Oncology
b Novel ADC continues on path to blockbuster status By www.thepharmaletter.com Published On :: Thu, 07 May 2020 15:39:00 +0100 Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan… Full Article Asia Pacific/AstraZeneca/Biotechnology/Daiichi Sankyo/Enhertu/Focus On/Japan/Oncology/Regulation/Research/trastuzumab deruxtecan/UK
b Dr Reddy's gets FDA nod for migraine drug Elyxyb By www.thepharmaletter.com Published On :: Thu, 07 May 2020 16:10:00 +0100 Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker… Full Article Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA
b Teva soars as 1st-qtr beats expectations By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:21:00 +0100 Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,… Full Article Ajovy/Analgesia/Austedo/Copaxone/Financial/Generics/Israel/Musculoskeletal/Rare diseases/Teva Pharmaceutical Industries/Treanda
b B-MS’ quarterly financials exceed estimates By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:36:00 +0100 US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,… Full Article Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA
b BetterLife Pharma inks licensing deal for AntiCovir By www.thepharmaletter.com Published On :: Fri, 08 May 2020 13:48:00 +0100 Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement… Full Article Altum Pharmaceuticals/Anti-virals/AntiCovir/BetterLife Pharma/Biotechnology/Canada/Coronavirus/Deals/Focus On/Licensing/Research
b FDA backs Retevmo for certain lung and thyroid cancers By www.thepharmaletter.com Published On :: Sat, 09 May 2020 12:27:00 +0100 The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules… Full Article Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA
b BRIEF—AbbVie finally completes acquisition of Allergan By www.thepharmaletter.com Published On :: Sat, 09 May 2020 14:18:00 +0100 US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,… Full Article AbbVie/Allergan/Companies mergers and acquisitions/Ireland/Legal/Pharmaceutical/USA
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b 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
b LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments By www.justice.gov Published On :: Thu, 22 Jan 2009 11:57:56 EST Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry. Full Article OPA Press Releases
b Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair By www.justice.gov Published On :: Thu, 22 Jan 2009 14:28:08 EST A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair. Full Article OPA Press Releases
b Twentieth Member of Casino-cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada By www.justice.gov Published On :: Thu, 22 Jan 2009 17:38:03 EST Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the Tran Organization, in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats. Full Article OPA Press Releases
b Former New York Power Authority Employee Sentenced to 37 Months in Jail for Bribery and Fraud Scheme By www.justice.gov Published On :: Fri, 23 Jan 2009 13:22:43 EST A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme. Full Article OPA Press Releases
b Canadian Company to Pay U.S. More Than $1 Million Related to Sale of Defective Bullet-proof Vests By www.justice.gov Published On :: Fri, 23 Jan 2009 16:03:49 EST Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles. Full Article OPA Press Releases
b Justice Department Settles Allegations of Disability and Religious Discrimination Against Nashville, Tenn. By www.justice.gov Published On :: Thu, 29 Jan 2009 10:39:59 EST The Department today announced a settlement resolving allegations that the Metropolitan Government of Nashville and Davidson County (Metropolitan Government) violated the Fair Housing Act (FHA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA) by discriminating against Teen Challenge, a Christian substance abuse treatment program. Full Article OPA Press Releases
b Former NFL Player, Ex-Casino Owner and Nevada Businessman Indicted in Massive Tax Fraud Scheme By www.justice.gov Published On :: Thu, 29 Jan 2009 11:46:41 EST A Las Vegas federal grand jury has returned an indictment charging Alan Rodrigues, a former pit boss and casino owner from Henderson, Nev.; Weston Coolidge, a businessman from Las Vegas; and Joseph Prokop, a former National Football League punter from Upland, Calif., with a tax fraud scheme for their promotion of a fraudulent tax product through the now defunct National Audit Defense Network (NADN). Full Article OPA Press Releases
b Justice Department Files Lawsuit on Behalf of North Dakota Army National Guard Member By www.justice.gov Published On :: Thu, 29 Jan 2009 12:12:55 EST The Department today filed a lawsuit on behalf of Suzanne L. Halverson, an Army National Guard member, against Grand Forks County, N.D., alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA), which prohibits employers from discriminating against service-members because of their past, current or future military service obligations. Full Article OPA Press Releases
b Justice Department Settles Lawsuit Alleging Gender Discrimination and Retaliation by the Puerto Rico Police Department By www.justice.gov Published On :: Fri, 30 Jan 2009 12:40:59 EST The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination. Full Article OPA Press Releases
b Eight Charged with Illegally Harvesting and Selling Striped Bass By www.justice.gov Published On :: Fri, 30 Jan 2009 17:45:58 EST Five commercial fishermen in St. Marys County, Md., a fish wholesaler, its owner and an employee have been charged in Maryland and Washington, D.C., for their role in the illegal harvest, sale, and purchase of hundreds of thousands of pounds of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007. Full Article OPA Press Releases
b Former Lobbyist Pleads Guilty to Conspiracy to Commit Honest Services Fraud By www.justice.gov Published On :: Fri, 30 Jan 2009 16:53:51 EST A former lobbyist pleaded guilty today to conspiring with others to commit honest services fraud. Todd A. Boulanger, 37, pleaded guilty before U.S. District Judge Richard W. Roberts in the District of Columbia. According to court documents, Boulanger worked as a lobbyist from 1999 through 2004 with Jack Abramoff and others. Full Article OPA Press Releases
b Final Defendant Pleads Guilty to Anti-Obama Assaults By www.justice.gov Published On :: Mon, 2 Feb 2009 14:58:36 EST Ralph Nicoletti pleaded guilty in Brooklyn, N.Y., federal court today before U.S. District Judge Carol B. Amon to committing three assaults targeting African-American residents in Staten Island, N.Y., on the night of President Barack Obamas election victory. Nicoletti was the last of four defendants to plead guilty in the federal prosecution stemming from the attacks. Full Article OPA Press Releases