Recon: Merck to buy Pandion Therapeutics for $1.85B; Bahrain authorizes J&J vaccine

• Democratic opposition could sink Woodcock’s chances to be nominated as permanent FDA commissioner (BioCentury) (Pink Sheet) (Endpoints)
• Pfizer-BioNTech testing booster of their COVID-19 vaccine in new trial (Reuters) (NBC)
• Moderna expects $18.4 billion in COVID-19 vaccine sales in 2021 (Reuters) (FT)
• Moderna produces Covid-19 shot targeting variant discovered in S Africa (FT)
• Regeneron to stop giving placebo in COVID-19 drug trial after 'clear efficacy' (Reuters)
• GSK narrows focus on elderly in trial to treat pneumonia from COVID-19 (Reuters) (STAT)
• Head of McKinsey Is Voted Out as Firm Faces Reckoning on Opioid Crisis (NYTimes)
• Merck to Buy Autoimmune Drug Developer for $1.85 Billion (Bloomberg) (Fierce) (Endpoints)
• A US court ruling may force biologics makers to review patent protections (STAT)
• Former AveXis executives launch gene therapy startup with uncommon targets (BioPharmaDive) (Endpoints)

• In boost for COVID-19 battle, Pfizer vaccine found 94% effective in real world (Reuters)
• AstraZeneca says it will have no vaccine supply shortfall in second quarter, EU wary (Reuters)
• EU leaders seek ways to speed up vaccine rollout in race against variants (Reuters)
• EU vaccine woes shift from supply squeeze to rollout (FT)
• China approves two more domestic COVID-19 vaccines for public use (Reuters)
• Health authorities call for common approach to COVID-19 treatments: EU (Reuters)
• African Union backs call to waive intellectual property rights on COVID-19 drugs (Reuters)
• Africa will pay more for Russian Covid vaccine than ‘western’ jabs (FT)
• Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use (Reuters)
• WHO says working with EC to manage regional COVID vaccine donations (Reuters)
• Sanofi, following Denali, pens gene therapy pact with Sirion Biotech (Fierce)

• Trends in COVID-19 therapeutic clinical trials (Nature)
• More high-tech manufacturing space for a global vaccine push (Reuters)
• Fraud fears and messy data stall FEMA program for Covid victims (Politico)
• Debilitating 'long-COVID' may have severe health, social impacts: WHO (Reuters)
• Syria says it has received COVID-19 vaccinations from 'friendly country' (Reuters)
• Japan to Start Elderly Vaccine Rollout from April 12: Minister (PharmaJapan)
• CEOs Face Grilling On Vaccine Supply In EU (Pink Sheet)
• CytoDyn has data on its highly touted experimental Covid treatment. Investors and patients don’t (STAT)
• EU countries report offers for 900 million COVID vaccines by 'alleged intermediaries': anti-fraud body (Reuters)
• Fraudsters offer 400 million 'ghost' COVID vaccines in EU: officials (Reuters)
• Nicaragua says gets first vaccines with Russia's Sputnik V (Reuters)
• South African medical schemes may no longer need to subsidise COVID vaccines – executives (Reuters)
• UK industry pushes for pre and post-vaccination roles for COVID-19 antibody tests (MedtechDive)

• Guidance for 'specials' manufacturers (MHRA)
• Risdiplam in Type 1 Spinal Muscular Atrophy (NEJM)
• Discarded drugs: a wasteful and costly problem that requires whole-of-government approaches (STAT)
• Fledgling CDMO Lakes BioScience blueprints $490M antibody factory at ex-GlaxoSmithKline site (Fierce)
• Challenging the link between statins and muscle pain, patients report no difference in aches when taking drug or placebo (STAT)
• Flagship upstart Cellarity gathers $123M to finance its exploration of cell behavior, blazing a new path to building a broad pipeline (Endpointsfxi)
• Nichi-Iko Likely to Face Biz Suspension Order over Spate of Recalls (PharmaJapan)
• Novo Nordisk plots $82M tablet capacity upgrade for diabetes blockbuster-to-be Rybelsus (Fierce)
• With $900M IPO, SK Bioscience has big plans for manufacturing expansion—even beyond COVID-19 vaccines (Fierce)
• Dutch biotech Intravacc seeks to bolster Netherlands vaccine manufacturing abilities with new plants (Endpoints)
• Follow biotechs going public with the Endpoints News IPO Tracker (Endpoints)
• NICE issues draft guidance recommending sapropterin for PKU in children (Pharmafile)
• EU Decision Time On Expanded Use Of BMS/Ipsen Pharma Cancer Drug Combo (Pink Sheet)
• Sentynl Signs Deal With Fortress’ Cyprium For ‘De-Risked’ Rare Disease Drug (Scrip)
• Novartis Says It Hired Over 1,600 Amid Job Cuts Speculation In India (Scrip)
• MHLW Formally Adopts GS1 Codes for Electronic Package Inserts; Rule to Take Effect August 1 (PharmaJapan)
• Xencor, UCLA to partner for new therapeutic antibodies; Schrödinger expands partnership with Google Cloud (Endpoints)
• S&P expects steady erosion in Big Pharma's credit profile in 2021 as new M&A deals roll in — but don't underestimate their underlying strength (Endpoints) (STAT)
• HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis (Press)
• Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia (Press)

• When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views (MedtechInsight)
• UK adopts medical device legislation, setting stage for new databases and sanctions (MedtechDive)
• Otsuka, Click Therapeutics kick off decentralized pivotal trial for depression digital therapeutics (mobihealthnews)
• Medtronic Claims Share Gains In Cardiovascular And Neurostim (MedtechInsight)
• Eli Lilly to connect its upcoming digital insulin pen with Welldoc’s diabetes app (Fierce)
• Nevro predicts resurgent pain implant sales in 2021 after slow start to the year (MedtechDive)
• Beware EUA Deprioritization! (FDA Law Blog)

• 4 takeaways from Xavier Becerra’s confirmation hearings (Politico)
• Zofran Birth Defect MDL Finally Heading For Trial In Fall (Law360)
• Moderna Asks Fed. Circ. To Undo Drug-Delivery Patent Ruling (Law360)
• EPA Hazardous Pharma Waste Rule Has Wide Reach (Law360)
• Justices Urged To Fix Fed. Circ. 'Paradox' In Heart Drug Case (Law360)
• Nevro Lobs New Suit At Boston Scientific Over Spine Pain IP (Law360)