Recon: EU threatens to curb COVID vaccine exports; Pfizer to halt biosimilar manufacturing in China

• FDA extends review period for expanded use of Abbvie's arthritis drug (Reuters)
• Democrats treading lightly on Biden’s next big health care promise (Politico)
• Pharma wins a round in a battle with HHS over a drug discount program for hospitals (STAT) (Law360) (Endpoints)
• Washington may become the second state to distribute its own generic drugs (STAT)
• Pfizer execs say there's a 'significant opportunity' to hike prices of its COVID vaccine (Insider)
• US could start vaccinating young kids in early 2022, Dr. Fauci says (CNBC)
• US talking to several countries about extra COVID-19 vaccine: Biden (Reuters)

• EU 'should probably help Russia' with Sputnik V vaccine, Commissioner says (Reuters)
• Facing 'crisis of century', EU threatens ban on COVID vaccine exports to UK (Reuters 1, 2) (Endpoints)
• Political role under fire in European AstraZeneca vaccine suspensions (Reuters)
• WHO statement on AstraZeneca COVID-19 vaccine safety signals (WHO)
• Six EU countries raise concerns over COVID jabs distribution: official (Reuters)
• India backs AstraZeneca shot as COVID-19 cases hit three-month high (Reuters)
• Pfizer to halt biosimilar output in China, sell assets to WuXi Biologics (Reuters)
• COVAX vaccine-sharing scheme to send out 'hundreds of millions' of J&J shots (Reuters)
• Catalent to ramp up J&J vaccine production at Italian plant (Reuters)

• Vietnam says homegrown COVID-19 vaccine to be available by fourth quarter (Reuters)
• Further MHRA response to the precautionary suspensions of COVID-19 Vaccine AstraZeneca (MHRA)
• AstraZeneca and Catalent defend Covid vaccine manufacturing process (FT)
• Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant (NEJM)
• Interim recommendations for the use of the Janssen Ad26.COV2.S (‎COVID-19)‎ vaccine: interim guidance, 17 March 2021 (WHO)
• EMA In The Clear Over Transparency In COVID-19 Product Assessments (Pink Sheet)
• Inside Africa's world-leading coronavirus supply chain (The Hill)
• Australian regulator says AstraZeneca vaccine rollout to continue (Reuters)
• Kazakhstan suspends talks on buying AstraZeneca vaccine (Reuters)

• Pharma is riding a vaccine high, but reputational risks loom (FT)
• Top companies and drugs by sales in 2020 (Nature)
• US FDA's On-Time Review Decision Rates Slips During The Pandemic, Especially For Biosimilars (Pink Sheet)
• Biotech start-up behind AstraZeneca jab raises $168m (FT)
• Observational Study Hurdles: From Data Blinding To Data Sharing (Pink Sheet)
• Advanced Cancers Are Emerging, Doctors Warn, Citing Pandemic Drop in Screenings (NYTimes)
• Do Two Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus? (Validant)
• UK’s NICE Namuscla Decision A ‘Red Flag’ For Repurposed Medicines (Pink Sheet)
• Global Blood takes on more sickle cell drugs through Sanofi deal (BioPharmaDive)
• MHLW to Continue Looking into Cause of Generic Scandals: Minister (PharmaJapan)
• CureApp Hypertension Therapeutic App Hits PIII Goal, 2021 Submission Eyed (PharmaJapan)
• Bluebird's top doctor to depart as company grapples with safety review (BioPharmaDive)
• Montreal AI startup with a touted advisor licenses its 'few-shot' platform to Repare for synthetic lethality molecules (Endpoints)
• Dean Li invites another under-the-radar biotech to Merck's dealmaking table as Amathus signs neurodegeneration pact (Endpoints)
• Eli Lilly, Novartis back a biotech startup boasting 'best of both worlds' protein degraders (Endpoints)
• Fresh out of the bluebird bio oncology split, Joanne Smith-Farrell flies the coop to Be Bio and its B cell platform (Endpoints)
• After a roller coaster ride, Sage COO strikes out on his own to chart a new biotech path (Endpoints)

• FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions (MedtechDive)
• Bayer posts second analysis of Essure adverse events taken from social media (MedtechDive)
• CMS puts the brakes on breakthrough device coverage rule (MedtechDive)
• Device Firms In Non-EU Markets Using The CE Mark Should Expect Some MDR Disruption After May (MedtechInsight)
• Abbott halts trial enrollment for HeartMate PHP catheter blood pump (MedtechDive)
• GE Healthcare announces its first wireless portable ultrasound device (mobihealthnews)
• NovaSight eyes FDA clearance with upcoming clinical trial (mobihealthnews)
• Singapore HSA will require government accreditation for certification bodies issuing ISO 13485 certificates (Emergo)

• When Is Skinny Not Skinny Enough? (FDA Law Blog)
• Senate Passes Bill on Advancing Education on Biosimilars (Big Molecule Watch)
• Generics Call Alcon Glaucoma Drug Obvious As Trial Begins (Law360)
• AstraZeneca Resets FTC Review Clock For $39B Alexion Deal (Law360)
• PhRMA Can't Get Minn. Insulin Pricing Law Overturned (Law360)
• McKinsey Opioid Deal With NY AG Approved Amid Objections (Law360)
• AbbVie Denies Judge-Shopping In Humira Kickback Cases (Law360)