Recon: EU signs deal for AZ COVID vaccine; FDA approves Cassiopea’s acne drug Winlevi

• Trump has launched an all-out attack on the FDA. Will its scientific integrity survive? (STAT)
• Novavax CEO expects filing for COVID-19 vaccine approval in December: paper (Reuters)
• Foundation Medicine wins FDA approval for liquid biopsy able to detect mutations in multiple cancers (STAT)
• Hahn spotlights Oct 22 vaccine advisory meeting as the next big flash point in the Covid-19 campaign (Endpoints)
• That pipeline AbbVie acquired in the $63B Allergan buyout? It’s not doing so well (Endpoints)
• Cassiopea gets FDA approval for acne treatment Winlevi (Reuters) (Endpoints)
• Trump administration asks Supreme Court to reinstate abortion pill rule (The Hill)

• EU signs contract with AstraZeneca on supply of potential COVID-19 vaccine (Reuters)
• China says halt of coronavirus vaccine partnership unrelated to Canada relations (Reuters)
• J&J adds Chile, Argentina and Peru to Latin America COVID-19 vaccine trials (Reuters)
• BioNTech, China's Fosun to potentially supply 10 million doses of COVID-19 vaccine (Reuters)
• Regeneron to add 400 jobs in Limerick as Covid treatment shows promise (The Irish Times)
• Boehringer calls off €627M deal with GSK spinout, passing on schizophrenia drug option (Endpoints)
• Conditional approval for Hansa's kidney transplant drug (PharmaTimes)
• GSK bags EU approval for Blenrep (PharmaTimes)
• New WHO technical package to help countries improve health data for COVID-19 response and beyond (WHO)

• US says testing not needed for some exposed to COVID-19, sparking outcry (Reuters) (NYTimes)
• DOJ may investigate blue states over Covid-19 deaths at nursing homes (Politico)
• What if the First Coronavirus Vaccines Aren’t the Best? (NYTimes)
• Novacyt launches test to differentiate COVID-19 and flu (Reuters)
• Sens. Warren, Smith press major labs over coronavirus testing delays as flu season approaches (CNBC)
• AstraZeneca broadens coronavirus vaccine manufacturing deal with Catalent (BioPHarmaDive)
• US Army taps Florida CDMO Ology with $106M work order for COVID-19 shots, therapeutics (Fierce)
• US doctors group calls for transparency in COVID-19 vaccine development (Reuters)
• New Covid-19 testing guidelines, crafted at the White House, alarm public health experts (STAT)
• Will supply chain demands freeze Pfizer and BioNTech out of a big chunk of the Covid-19 market? (Endpoints)

• FDA drops boxed warning from Johnson & Johnson's diabetes drug label (Reuters)
• MHLW to Accept Sakigake Applications All Year Long under Amended PMD Law (PharmaJapan)
• Ex-Celgene exec steers his biotech startup to Hong Kong IPO as potential cancer drug launch looms (Endpoints)
• Irish Regulator Pilots New Forum To Include Patient Input In Decisions (Pink Sheet)
• Brazilian Industry Pushes For Clinical Research Bill To Proceed (Pink Sheet)
• Responding To FDA 483s And Warning Letters: Some Dos, Don’ts And Red Flags (Pink Sheet)
• Bayer backs Triumvira to take CAR alternative into clinic (Fierce)
• Clene Nanomedicine, researching the use of gold atoms to slow ALS progression, nets $42.5M Series D (Endpoints)
• Antibiotics May Interfere With Hormonal Contraceptives (NYTimes)
• Triumvira snags $55M Series A to guide TAC technology to the clinic (Endpoints)
• Tizona completes spinout of cancer program as part of Gilead buyout; Dyne files for $100M IPO (Endpoints)
• A Forbion-funded startup bought the rights to Amgen's CETP inhibitor, and is giving the cholesterol drug another go (Endpoints)
• Synthego adds $100M from RA, Wellington, 8VC in pursuit of 'virtualizing biology (Endpoints)
• NCI, Cancer Research UK launch Cancer Grand Challenges partnership to support bold new ideas for cancer research (Press)

• With a one-year reprieve to EU's MDR, some procrastinate, others speed ahead (MedtechDive)
• Industry Makes Final Arguments Against PUPSIT Before EC Decides On EU GMP Annex 1 Revision (Pink Sheet)
• Bayer reinvests in digital health maven One Drop, with $98M in commitments (Fierce)
• Freenome secures $270M to boost its colorectal cancer blood test, expand trial nationwide (Fierce)
• Amazon debuts wrist wearable Halo, marking its entry into health tracking (STAT)
• US FDA releases catalog of regulatory science tools (Emergo)
• Google Health, Philips among players pitching digital therapeutics standards (MedtechDive)
• Hologic inks $80M Acessa buyout to expand women's health business (MedtechDive)

• Trump admin delays final rule easing anti-kickback regs until next August (MedtechDive)
• Publishing OTC medicine PIs and CMIs on the TGA website (TGA)
• Creating the CMI summary page - Guidance for sponsors (TGA)
• The Growing Challenges To Drug Cos.' Preemption Defense (Law360)
• Pharmacies Torch 'Unprecedented' Ruling On Opioid Duties (Law360)
• Amgen Blasts Sandoz's En Banc Bid In Enbrel Patent Fight (Law360)