Recon: Valneva secures EU deal for its vaccine; TGA requests additional info from Pfizer after BMJ report

• Pfizer seeks FDA nod for COVID vaccine boosters for U.S. adults (Reuters) (NYTimes)
• Moderna and U.S. at Odds Over Vaccine Patent Rights (NYTimes)
• Theranos lab deficiencies posed ‘immediate jeopardy’ to patients, 2016 government audit warned (CNBC)
• Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use (MedtechDive)
• Company that sold overdose antidote to pay $12.7 million to settle charges of fraudulent scheme (STAT) (DOJ)

• TGA requests information from Pfizer after medical journal alleges contractor ‘falsified’ safety data (News.com.au)
• Roche executive says Alzheimer's drug price will be competitive (Reuters)
• Valneva shares soar on EU deal for COVID-19 vaccine (Reuters) (FT)
• EU to decide on Moderna's COVID-19 shot for younger kids in two months (Reuters) (EMA)
• Japan to pay $1.2 billion for 1.6 mln courses of Merck's COVID-19 pill (Reuters)
• Germany recommends only Biontech/Pfizer vaccine for under-30s (Reuters)
• Pfizer applies for COVID-19 vaccine approval for 5-11 year olds in Japan (Reuters)
• Canadian Drugmaker Apotex Is Said to Revive Sale Talks (Bloomberg)

• UK researchers identify T-cell targets for future COVID vaccines (Reuters)
• U.S. brokers J&J-COVAX deal to send vaccines to conflict zones -Blinken (Reuters)
• Moderna's COVID-19 vaccine (SPIKEVAX) - provisional determination granted for proposed use in children and booster shot for adults under evaluation (TGA)

• Industry Fears Report-Writing Burden From Supply Chain Risk Guidance US FDA Is Drafting (Pink Sheet)
• Clinical development times for innovative drugs (Nature)
• The very slow roll of Biogen's Aduhelm: Neurologists weigh in on patients, practices and payments amid ongoing media storm (Endpoints)
• Largest psilocybin trial finds the psychedelic is effective in treating serious depression (STAT)
• FibroGen cuts jobs as it weighs anemia drug's future in US (BioPharmaDive)
• Bill and Melinda Gates Foundation backs little-known biotech going after Pfizer, Merck on pneumococcal vaccine (Endpoints)
• Ligand to split in half, spinning OmniAb platform into its own company (Endpoints)
• EQT Group acquires VC firm in $500M+ deal; Sanofi selects IPO leaders for 2022 API spinout — report (Endpoints)
• On the heels of solid tumor data and with competitors surging, Poseida scraps autologous CAR-T in favor of allo (Endpoints)
• Genentech teams with little Novome on IBD research, looking to colonized bacteria after a severe setback (Endpoints)
• Without ability to force recalls, FDA can only warn consumers about benzene in hand sanitizers (NBC)
• Takeda-backed Poseida puts off-the-shelf CAR-T in its basket, places autologous therapy back on the shelf (Fierce)
• CPhI: Regulatory changes have led to a CMO boom in China, but can that continue? (Endpoints)

• Robotics startup Vicarious files pre-submission with FDA, fresh from $425M SPAC raise (MedtechDive)
• Coloplast acquires laryngectomy device maker Atos Medical in $2.5B takeover (MedtechDive)

• Purdue Agrees Not To Finalize Ch. 11 Plan Until Appeals Done (Law360)
• Fed. Circ. Upholds Roche's Win In Cancer Therapy IP Review (Law360)
• What Fraud on the FDA Really Looks Like (Drug & Device Law)
• Oklahoma court overturns $465 million opioid verdict against Johnson & Johnson (STAT)