Recon: FDA orders Emergent to halt vaccine production during inspection; Adagio raises $336M to advance COVID antibody treatment

• FDA orders J&J contractor Emergent to stop vaccine production during inspection (Politico) (Reuters) (Endpoints) (SEC filing)
• Doctors say clot treatment advice key to U.S. resuming J&J COVID vaccines (Reuters)
• J&J scientists refute ‘class effect’ to blame for clots in those who got its COVID-19 vaccine (Reuters)
• J&J, others face California trial over claims they fueled opioid epidemic (Reuters) (WSJ)
• When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area (Endpoints) (Law360) (FDA Law Blog)
• Adagio raises $336 million to advance Covid-19 antibody treatment (STAT)
• Half of US adults now have received at least 1 Covid shot (Politico)
• Biden Administration Ends Limits on Use of Fetal Tissue for Research (NYTimes)

• EU secures additional 100 mln COVID-19 doses from Pfizer/BioNTech (Reuters)
• China trials mixing of CanSinoBIO's and Zhifei Longcom's COVID-19 vaccines -data (Reuters)
• China is starting clinical trials of a Covid vaccine that can be inhaled (CNBC)
• India to fund capacity boost at Serum Institute, Bharat Biotech as vaccines run short (Reuters)
• Italy seeks domestic production of mRNA Covid vaccines (FT)
• Brexit red tape threatens drugs supplies in Northern Ireland (FT)
• NICE launch ambitious five-year patient access strategy (Pharmafile)
• MHLW to Revoke Approval of 12 Kobayashi Kako Products as Documents Fabricated (PharmaJapan)

• South Africa health regulator recommends resuming Johnson & Johnson vaccinations (FT)
• Austria will only use Sputnik V vaccine after EMA approval, Kurz says (Reuters)
• Young people to be reinfected with Covid for study (BBC)
• Pharma companies cut remdesivir injection prices on govt intervention: NPPA (Economic Times)
• The Covid-19 Plasma Boom Is Over. What Did We Learn From It? (NYTimes)

• Opinion: Drug Safety Is FDA’s Job, Not CDC’s (WSJ)
• Opinion: The FDA should embrace remote and automated drug inspection technology (STAT)
• Pipeline pressure and Elliott’s stake have GSK in a spin (FT)
• Seagen gets August PDUFA for Padcev expansions; Adaptate pulls in new cash for gamma delta T cell antibodies (Endpoints)
• Positive data in hand, TG Therapeutics readies MS drug for FDA review (BioPharmaDive)
• Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021 (Pink Sheet)
• Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval (Pink Sheet)
• EC approves new Sarclisa indication (PharmaTimes)
• FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma (FDA)
• Q1: A flood of investor cash drove biotech's numbers to new record highs, and the torrent of cash is moving upstream fast (Endpoints)
• New Kaiser analysis shows how limiting price negotiations to targeted drugs may better focus upcoming legislation (Endpoints)
• FDA slaps a hold on Moffitt’s next-gen CAR-T as regulators demand another delay on clinical work — shares crater (Endpoints)
• Jami Rubin, once fabled for grilling biopharma execs, decamps to head finance at drug pricing disrupter (Endpoints)
• The doctor is in: Trump insider Ben Carson joins NASH player Galectin as a 'special consultant,' part-time spokesman (Endpoints)
• Biotech's IPO raise approaches $5.5B as Nasdaq continues to prove fruitful with 2 debuts and three new filings (Endpointsv)
• Ovid cuts its losses on controversial Angelman syndrome drug, making its crushing development halt permanent (Endpoints)
• Facebook unveils AI model to mix up cancer-curing cocktails with existing drugs (Fierce)
• A Hundred Drugs Contend: Chinese Biopharma Gains US Foothold (Scrip)

• Medtronic taps IoT security startup Sternum to prevent pacemaker hacks (Fierce)
• FDA drops 8 medical software functions from oversight (MedtechDive)
• C2i Genomics lands $100M to scale up software that detects tiny traces of cancer in a single blood draw (Fierce)
• Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile (MedtechInsight)
• US FDA: Recall Of BD Alaris Infusion Pump Is High-Risk Class I (MedtechInsight)
• EU Medtech May Have Standards Certainty Days Before MDR Applies (MedtechInsight)
• Indian pharma exports grow at 18 percent to $24.44 bn in FY 21 (Economic Times)

• Advocacy groups outraged after a PBM offers a $500 gift card to persuade patients to switch drugs (STAT)
• What To Watch As Justices Eye Restriction On Patent Attacks (Law360)
• AstraZeneca Notches FTC Approval For $39B Alexion Deal (Law360)
• Late Bid For New Suboxone Antitrust Complaint Falls Flat (Law360)
• Opana Buyers Point To FTC's 5th Circ. Win Against Impax (Law360)