Recon: Hahn walks back claims about convalescent plasma efficacy; AstraZeneca begins COVID antibody trial

• FDA chief issues mea culpa for his plasma treatment claims (Politico) (Bloomberg) (AP) (STAT) (Pink Sheet)
• FDA ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say (NYTimes)
• We asked for biopharma's opinion about the plasma EUA. The industry offered a double-barreled response (Endpoints)
• Trump Keeps Promoting a Drug Order That No One Has Seen (NYTimes)
• Trump deadline for drug pricing order passes with no action (The Hill)
• Fauci says rushing out a vaccine could jeopardize testing of others (Reuters)
• FDA commissioner disputes Trump, says no 'deep state' thwarting vaccine (Reuters)
• Sun Pharma unit to pay $21M for giving docs false instructions for a skin treatment (STAT) (Economic Times)
• Urged on by scientists, NIH will study Gilead’s remdesivir-like compound against Covid-19 (STAT)
• Tricida 'foreshadowed' its CRL — but shares still fall with fear of years-long delay (Endpoints) (Fierce)

• Two more Hong Kong IPO filings, and Beijing’s latest drug price cuts (STAT)
• Oxford coronavirus vaccine data could go to regulators this year (Reuters)
• Takeda inks up to $500M collaboration with extra-cellular matrix biotech for NASH (Endpoints)
• China's Sinovac enters supply deal with Indonesia for COVID-19 vaccine doses (Reuters)
• AstraZeneca starts trial of COVID-19 antibody treatment (Reuters)
• Mexico signs up to Italian vaccine trial for coronavirus: minister (Reuters)
• Africa Celebrates the End of the Wild Poliovirus (but Not the End of All Polio) (NYTimes)

• US braced for political row over who gets first Covid-19 vaccines (Financial Times)
• Flu Season Could Make Coronavirus Testing Delays Even Worse (NYTimes)
• We don’t know if convalescent plasma is effective against Covid-19. With the emergency authorization, we might never know (STAT)
• Biogen conference likely led to 20,000 COVID-19 cases in Boston area, researchers say (Boston Globe)
• RNC tries to rewrite Trump's coronavirus record (Politico)
• EPA approves a virus-killing coating for American Airlines, studies use by schools (Reuters)
• Two European patients re-infected with coronavirus (Reuters)
• Thousands of Swedes got false positive COVID-19 result due to test kit fault (Reuters)
• Russia seeks collaboration with India for manufacturing Covid vaccine Sputnik V: Report (Economic Times)

• Big Pharma Needs a Covid-19 Vaccine to Redeem Its Reeling Reputation (Bloomberg)
• Pharma Rivals Are Fighting Covid Together. Why Stop There? (Bloomberg)
• Proteostasis bows out of cystic fibrosis drugmaking through Yumanity merger (BioPharmaDive)
• Rather Than Give Away Its COVID Vaccine, Oxford Makes a Deal With Drugmaker (KHN)
• Medication and Lifestyle May Lower Breast Cancer Risk (NYTimes)
• Acadia Pharmaceuticals buys pain drug maker, part of effort to expand on psychosis treatment (STAT)
• Pharmacists say they tell patients about physical changes to pills, but consumers say that isn’t always the case (STAT)
• AbbVie's Skyrizi stands to gain as docs move away from older psoriasis meds—Amgen's Otezla included (Fierce)
• AbbVie options integrin-based compounds from Morphic, paving way for potential fibrosis treatments (Endpoints)
• AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis (Press)
• Agios just sold off the royalty rights for $255M, but Bristol Myers says Idhifa was a bust in PhIII. Now what? (Endpoints) (Press)
• Troy Wilson recruits AstraZeneca vet to steer Kura's late-stage pivot (Endpoints)
• ATAI adds MDMA biotech to growing list of psychedelic makers; Acadia adds $52.5M upfront pain buyout (Endpoints)
• Blackstone bankrolls supply chain player's deal spree with $275M (Endpoints)
• Ovid gets quick raise off PhII seizure results. Can the results hold up against GW? (Endpoints)
• A small VC group expands its hunt for inspired biotech founders in need of seed cash (Endpoints)
• Connect Biopharma snags $115 million in Series C to develop arsenal of immune modulators (Endpoints)
• Rakuten Medical’s Sakigake-Designated Photoimmunotherapy Up for MHLW Panel Review on Sept.4 (PharmaJapan)
• Phase 2 ELEKTRA Study of Soticlestat (TAK-935/OV935) Meets Primary Endpoint Reducing Seizure Frequency in Children with Dravet Syndrome or Lennox-Gastaut Syndrome (Press)
• Consultation: Permissible ingredients annual changes 2020-21 (TGA)

• MedTech Europe beats drum for virtual audits, IVDR delay (MedtechDive)
• Ex-Trump FDA chief rails against new HHS policy on lab developed tests (MedtechDive)
• Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error (FDA)
• As Elon Musk’s Neuralink prepares to draw back the curtain, ex-employees describe rushed timelines clashing with science’s slow pace (STAT)
• Weil, Simpson Weld Medical Device Deal Worth Up To $825M (Law360)

• PTAB Upholds Entirety Of 3 Narcan Patents (Law360)
• Regeneron Says Feds' Kickback Suit 'Defies Common Sense' (Law360)
• Gilead Says Law Firm's Ads Misrepresent HIV Drug Suit (Law360)
• Dr. Reddy's Can Add Antitrust Allegations In Suboxone Row (Law360)
• Biotech Co. Lied About COVID-19 Vaccine, Investors Say (Law360)
• Court Looks To Streamline Dispute Between IQVIA And Veeva (Law360)
• DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act Allegations Relating To Promotion Of Unsupported Drug Administration Process (DOJ)
• Three Enter Pleas in Scheme to Import Rx Drugs and Fraudulent Credit Card Payment Processing Scheme (FDA)