Recon: FDA grants full approval to Pfizer’s COVID pill Paxlovid; Califf says US default would halt reviews

• US Debt Default Would Stop Drug, Device Reviews, FDA Chief Says (Bloomberg)       
• Medtronic's profit forecast hit by stronger dollar, inflation (Reuters)
• Exclusive: Icahn poised to win at least one seat on Illumina's board -sources (Reuters)
• Fresenius lifts 2023 outlook for hospital drugs unit Kabi (Reuters)
• Purdue Pharma to sell consumer business for $397 mln (Reuters)
• Sarepta says FDA may limit gene therapy nod to smaller population, shares fall (Reuters) (STAT)
• Pfizer's COVID pill Paxlovid gains full FDA approval (Reuters) (FDA)
• FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria (FDA)
• DEA’s failure to punish distributor blamed in opioid crisis raises revolving door questions (AP)
• Abbott, baby formula makers face FTC probe for potential collusion (Reuters)

• India's Biocon Biologics says biosimilars put revenue on $1 bln trajectory (Reuters)
• Boyu, Hillhouse, others vie for HK-based medical device firm Quasar -sources (Reuters)
• BioNTech is proceeding with COVID-shot in line with WHO guidance (Reuters)
• Obesity fighting success fuels Novo bet on gene-editing tech (Reuters)
• AbCellera to make C$701 million co-investment in Canada (Reuters)
• UK to announce funding boost for life sciences (FT)
• EU Pharma Revision: Legislators Prepare For Long-Haul Debate (Pink Sheet)
• Indian labs to give 'top priority' to tests on cough syrup exports – regulator (Reuters)
• MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines (MHRA)

• Ketamine is comparable to ECT for patients with treatment-resistant depression, study shows (STAT)
• Annexon’s trial of an eye disease drug missed by a mile. The company saw a bull’s eye (STAT)
• Rich Horgan spearheaded a gene therapy for his brother. The trial ended in tragedy, but the work continues for more patients (Endpoints)
• Mirati's long wait for next lung cancer med ends in phase 3 failure (Fierce)
• BioXcel looks to expand label to at-home use for lead psych drug. Initial data are mixed (Endpoints)
• Lilly gears up trio of PhIII trials for its oral GLP-1 amid Novo Nordisk, Pfizer competition (Endpoints)
• Apellis reports PhII ALS fail after stopping open-label extension in April (Endpoints)
• Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma (Fierce)
• Boehringer Ingelheim extends 2020 collab with Oxford BioTherapeutics; European biotechs claim positive PhI I/O data (Endpoints)
• BenevolentAI lays off around 180 staffers, cuts pipeline programs in reorg (Endpoints)
• Veeva adds generative AI tool for pharma reps as it rolls out new software platform (Endpoints)
• UCB enters gene therapy space, inking license agreement for epilepsy and neurodegeneration research (Endpoints)
• CDMO secures a $98M+ NIH contract for production of pediatric HIV-prevention products (Endpoints)

• Integra recalls all devices made at Boston facility in the past 5 years, pauses production (Medtech Dive) (Medtech Insight)
• Abbott cuts 199 jobs amid dwindling demand for COVID tests (MedtechDive)
• FDA teams with Veterans Health Administration to make medtech supply chains more resilient (MedtechDive)
• Cybersecurity Skills Shortage In EU ‘Untenable’ Warns Medtech Trade Body (Medtech Insight)

• Will Medicare cover it? Drugs like Aduhelm are challenging its standard (STAT)
• Medicaid plans to audit the prices of costliest drugs (AP)
• Abortion pill maker seeks to keep challenge to W. Va. abortion ban alive (Reuters)
• District court hands Janssen a win in patent feud with Viatris (Endpoints)
• After years of litigation, Gilead and Teva's HIV antitrust trial kicks off in California (Fierce)