Recon: FDA confirms widespread Adderall shortages; India finds violations at drugmaker linked to Gambia deaths

• FDA Confirms Widespread Shortages of Adderall (NYTimes) (Reuters)
• Pfizer, BioNTech find updated COVID booster protects against Omicron in trial (Reuters)
• Merck opts to develop, sell cancer vaccine with Moderna (Reuters) (STAT)
• Novavax says COVID booster dose shows benefit against Omicron variants (Reuters)
• Relmada's stock sinks after depression drug defeated by 'outperforming' placebo (Fierce) (Reuters) (STAT)
• FDA and large compound pharmacies settle a long-running dispute over a key list for ingredients (STAT)

• India finds serious violations at firm linked to Gambia deaths, suspends production (Reuters)
• India tells Gambia it is probing childrens' deaths linked to India-made drugs (Reuters)
• Indian state drug regulator orders sample checks on all oral liquid solutions - CNBC TV18 (Reuters)
• AstraZeneca is fined by South Korea for an anticompetitive deal over a cancer drug (STAT)
• RSV vaccine race heats up with highly effective GSK shot (Reuters)
• Beijing’s failure to import mRNA Covid jabs ‘mind-boggling’, says BeiGene executive (FT)
• GSK hails respiratory virus jab after positive trial results (FT)
• Novartis to cut its Irish workforce by up to 25% (Reuters) (Fierce)
• Vaccine trials on Sudan Ebola strain to start in weeks - WHO chief (Reuters)
• Europe likely entering another COVID wave, says WHO and ECDC (Reuters)

• Differences in countries’ regulations keep some cell and gene therapies from reaching patients (STAT)
• BioMarin gets FDA decision date for hemophilia gene therapy, but questions on review remain (BioPharmaDive)
• BridgeBio's $2.4B partnership takes a sudden hit as Helsinn plans to withdraw NDA on FGFR2 drug (Endpoints)
• Inotrem’s phase 2 data sparks hope for septic shock treatment (Fierce)
• J&J and Sanofi-partnered oral delivery biotech raises $26M on latest offering (Endpoints)
• REMS Integration Into Electronic Health Records To Be Tested By US FDA In Software Pilot (Pink Sheet)
• Requiring FDA Guidances Does Not Always Advance The Science, Gene Therapy Director Says (Pink Sheet)
• Lineage Cell Therapeutics opens new California R&D facility and expands Israel manufacturing site (Endpoints)
• With data from nine-patient study, VectivBio raises $125M ahead of lead program's big readout (Endpoints)
• Ionis to build new manufacturing site in Southern California, doubling the size of its current site (Endpoints)
• GSK drops commercial duties in Kenya, shifts to distributor model (Endpoints)

• Sony begins sale of OTC hearing aids with entry-level price of $999 (MedtechDive)
• Orthofix And SeaSpine Plan Merger To Create Billion-Dollar Spine And Ortho Company (MedtechInsight)
• Roche launches ‘2.0’ antigen tests for COVID’s long road ahead (Fierce)
• Nevro nabs FDA approval for spinal cord stimulator that uses AI to personalize pain treatment (Fierce)
• Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says (MedtechDive)
• GE advances healthcare spinoff plan, providing close look at workings of the unit (MedtechDive)

• Jury Backs C.R. Bard In AngioDynamics Antitrust Case (MedtechInsight)
• Fed Circ. Urged To Undo PTAB's Gene-Editing Patent Ruling (Law360)
• Sandoz Fights FDA Exclusivity For Sanofi MS Drug At DC Circ (Law360)