Recon: US court voids $448M award against AbbVie; FDA lifts hold on Solid Biosciences’ gene therapy trial

• FDA widens US safety inquiry into AstraZeneca coronavirus vaccine (Reuters) (FT)
• US court voids $448M award against AbbVie, revives FTC AndroGel claim (Reuters) (Law360) (STAT)
• Fujifilm signs manufacturing contract with U.S. firm VLP for COVID-19 vaccine (Reuters)
• Congress makes final play for coronavirus aid package (Politico)
• Solid Biosciences says FDA lifts halt on gene therapy trial, shares soar (Reuters)
• The Endpoints 11: Here are some of the most promising startups in biotech (Endpoints)
• For the first time, drug makers and PBMs must jointly face an insulin price fixing lawsuit (STAT)
• Novartis, Amgen and Mallinckrodt used aggressive price hikes to meet sales goals, congressional probe finds (Fierce)
• Sky-High Drug Prices Driven by Pharma Profits, House Dems Charge (KHN) (STAT) (Pink Sheet)

• Brazil's Sao Paulo signs agreement with Sinovac for COVID vaccine doses (Reuters)
• Chile approves clinical trials for Sinovac, J&J coronavirus vaccines (Reuters)
• AbbVie withdraws uterine fibroids drug from Canada (Reuters)
• France to enrol 25,000 in COVID-19 vaccines clinical trials (Reuters)
• GAVI providing $150 million to poorer countries to prepare for COVID-19 vaccines (Reuters)
• Bayer shares slump on profit warning as pandemic bites deeper (FT)

• Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it (CNBC)
• The FDA and the Importance of Trust (NEJM)
• Rethinking Covid-19 Test Sensitivity — A Strategy for Containment (NEJM)
• White House Blocked C.D.C. Order to Keep Cruise Ships Docked (NYTimes)
• Japan Govt Plans Free Coronavirus Vaccinations to All Citizens (PharmaJapan)
• Can The US Use Its Growing Supply Of Rapid Tests To Stop The Virus? (NPR)
• Web Of 'Wellness' Doctors Promote Injections Of Unproven Coronavirus Treatment (NPR)
• Israel's Enlivex reports positive results in COVID-19 drug trial (Reuters)
• The Mask Hypocrisy: How COVID Memos Contradict the White House’s Public Face (KHN)

• US FDA Heads Into October With Calm Approvals Forecast (Pink Sheet)
• FDA sets November date for expert panel review of Biogen’s aducanumab (PMLive)
• The biotech scorecard for the fourth quarter: 18 stock-moving events to watch (STAT)
• Roche shells out $200M for rights to Vaccibody's neoantigen cancer vaccine (Endpoints)
• EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer (EMA)
• Novartis cites ‘transformative’ data on Zolgensma as it rolls out SMA gene therapy in Europe (Fierce)
• With a new CEO, a small biotech is out to prove Wall Street wrong (STAT)
• Tennessee packaging company drops $21M into 'state-of-the-art' facility for push into cold chain, biologics (Fierce)
• HPV vaccine significantly lowers risk of cervical cancer, large study finds (NBC)
• Major Milestone For Diurnal As FDA Approves Alkindi (Scrip)
• CDMO Sterling Pharma continues buying spree with former Alcami ingredients plant pickup (Fierce)
• Mesoblast asks for trading halt as PDUFA date slides by. What's up? (Endpoints)
• Hims, a direct-to-consumer health company, is going public via SPAC (CNBC)
• Metformin Cancer Risk Acceptable at 1 in 550,000 Patients: NIHS Assessment (PharmaJapan)
• Shionogi Grabs Global Rights for Univ. of Tokyo Spin-Off’s Novel S. Pneumoniae Nasal Vaccine (PharmaJapan)
• News briefing: Poxel flashes early positive NASH results; Ionis teams up with AI-focused Genuity Science (Endpoints)
• Bidding to be the go-to genomics and data partner for drug development, Sophia Genetics raises $100M (Endpoints)
• Its sale to Allergan was called off at the last minute. One year later, a biotech co-founded by Henri Termeer finds a new buyer (Endpoints)
• Genfit prunes nearly half its workforce after NASH exit — but CEO promises a future in PBC, diagnostics (Endpoints)
• A second Carl Icahn protégé jumps in on SPAC spree, as Alex Denner guns for $175M (Endpoints)
• Pfizer receives FDA fast track designation for duchenne muscular dystrophy investigational gene therapy (Press)

• US FDA Simplifies Variance Application Process For X-Ray Companies (MedtechInsight)
• BrainCool Seeks De Novo For Device That Prevents Oral Mucositis In Cancer Patients (MedtechInsight)
• 2020 amendments to IEC 62366 – implications for medical device usability engineering (Emergo)
• Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices (TGA)

• Prescription drug monitoring programs: Views on usefulness and challenges of programs (GAO)
• Courts Reject Demands to Force FDA to Approve Hydroxychloroquine for COVID-19 (FDA Law Blog)
• D.Mass Rejects Post-trial Motions by Corporate Officers Convicted of Off-Label Promotion (Drug & Device Law)
• New bill would create a subscription payment model to jumpstart antibiotic development (STAT)
• Immunomedics Hit With Investor Suit To Halt $21B Gilead Deal (Law360)
• Walgreens Asks 9th Circ. To Decertify Theranos Class (Law360)
• UK Court Rules Meril Infringes Edwards' Heart Valve Patent (Law360)
• Purdue Pharma Gets OK For Payments, Opioid Suit Shield (Law360)
• Teva Inks Patent Deal With Collegium Over Painkiller (Law360)
• Boehringer Ingelheim Wins Pradaxa Wrongful Death Suit (Law360)
• Alice Dooms DNA Analysis Patents In Biotech Co.'s Suit (Law360)