Regulatory Focus™ > News Articles > 2021 > 6 > Recon: UK authorizes Pfizer-BioNTech vaccine for adolescents ages 12-15; News from ASCO

Recon: UK authorizes Pfizer-BioNTech vaccine for adolescents ages 12-15; News from ASCO

Posted 04 June 2021 | By Michael Mezher 

Recon: UK authorizes Pfizer-BioNTech vaccine for adolescents ages 12-15; News from ASCO

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US authorizes lower dose of Regeneron's COVID-19 antibody therapy (Reuters) (Endpoints)
  • Investors, patients await FDA decision on Biogen Alzheimer's drug due Monday (Reuters)
  • Biden health official 'taking a look' at Trump drug pricing proposal (The Hill)
  • First US Vaccine Donations Will Go to ‘Wide Range’ of Nations in Need (NYTimes)
  • For first time, immunotherapy after surgery shows benefit for patients with early kidney cancer (STAT) (Endpoints)
In Focus: International
  • Russia expects WHO to approve Sputnik V vaccine within two months -RDIF (Reuters)
  • UK approves Pfizer/BioNTech COVID shot for 12- to 15-year-olds (Reuters) (MHRA)
  • Malaysia grants conditional approval for Thai-made AstraZeneca vaccine (Reuters)
  • Resisting patent waiver, EU submits vaccine plan to WTO (Reuters) (FT)
  • WHO warns of 'failure' unless rich countries speed up vaccine sharing (Reuters)
  • India yet to decide on indemnity for local makers of COVID-19 shots -official (Reuters)
  • #ASCO21: Novartis flashes 'groundbreaking data' for $2B radioligand drug (Endpoints) (BioPharmaDive) (NBC) (Press)
  • Cancer-Drug Showdown Pits China Upstarts Versus Pharma Cash Cows (Bloomberg)
  • After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug (STAT)
  • EU regulators develop recommendations to forecast demand of medicines (EMA)
Coronavirus Pandemic
  • Vulnerable people may need vaccine boosters this year, scientists say (FT)
  • NIH scientists say they may have found a promising new oral antiviral drug for Covid (CNBC)
  • Mexico to apply U.S.-supplied J&J shots to 18-40 year olds along border (Reuters)
  • Fauci calls on China to release medical records of Wuhan lab workers – FT (Reuters)
  • Blackwater founder Prince takes role in COVID vaccine venture (Reuters)
  • Government confident India will have over 2 billion vaccine doses by December, minister says (CNBC)
  • Sanofi to Manufacture COVID-19 Vaccine in Japan (PharmaJapan)
  • Zydus Cadila, first Indian Company gets permission for clinical trials of antibodies cocktail to treat COVID-19: Sources (Economic Times)
Pharma & Biotech
  • AstraZeneca moves finance chief to new role after Alexion deal (Reuters) (Endpoints)
  • AstraZeneca and Merck point to progress in fighting breast cancer (FT)
  • AstraZeneca drug prevents breast cancer caused by BRCA mutations from returning (STAT) (Endpoints)
  • CBER, ORA Saw FY 2020 User Fee Spending Drop Even As COVID Strained US FDA’s Resources (Pink Sheet)
  • Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020 (Pink Sheet)
  • US FDA Drug Center Director’s Top Priority: Winning ‘Hearts And Minds’ (Pink Sheet)
  • Biopharma supply chain security: FDA guidance spells out new expectations (Endpoints)
  • Shifting Trends In Marketing Approvals Of Orphan Drugs (Law360)
  • J&J touts Tremfya win in Humira-resistant psoriatic arthritis patients amid showdown with AbbVie's Skyrizi (Fierce)
  • Verily’s new big hire, Amy Abernethy, on her plans to transform clinical trials — and bring in money (STAT)
  • Martin Shkreli’s longtime friend wants to undo his 4,000% price hike. But first he’ll have to finally oust the ‘pharma bro’ (STAT)
  • #ASCO21: Gilead's Trodelvy reads out new subgroup data showing benefit in earlier-line TNBC patients (Endpoints)
  • #ASCO21: Coherus, Junshi hunt US approval for anti-PD-1 drug in nose and throat cancer with late-stage win (Endpoints)
  • #ASCO21: Nanobiotix says early data show 'very strong' signal that its nanoparticles can dial up antitumor response (Endpoints)
  • #ASCO21: Bristol Myers' solo, dual I/O regimens best chemo alone — with one exception — in first-line esophageal patients (Endpoints)
  • #ASCO21: SQZ offers first clinical glimpse of unorthodox cell therapy manufacturing tech — but checkpoint combo is still the way to go (Endpoints)
  • Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma (Press)
  • Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers (Amgen)
  • Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL) (Press)
  • Novartis investigational checkpoint inhibitor tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer after systemic therapy (Press)
  • Lilly Announces New Clinical Data from Verzenio and Oral SERD Programs at the American Society of Clinical Oncology Annual Meeting (Press)
  • Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC (Press)
  • Just months after SPAC reverse merger, Point Biopharma ups the ante at Indianapolis manufacturing site (Endpoints)
  • As companies dump money into manufacturing, where will they find the trained workers to man the lines? (Endpoints)
  • AavantiBio lands manufacturing partner in Friedreich's Ataxia program; NC Research Triangle lands another CDMO (Endpoints) (Fierce)
  • Amryt earns a priority review in a rare disease that makes patients' skin fragile as butterfly wings (Endpoints)
  • Corey Goodman's venBio closes latest VC fund — this time to the tune of $550M — with a dozen or more investments on deck (Endpoints)
  • A Belgian manufacturer looks to pit its freeze drying process against mRNA — and beyond (Endpoints)
  • As the mRNA push continues, Samsung will expand its drug substance manufacturing at South Korean hub (Endpoints)
  • Roche's oral SMA med Evrysdi turned down by UK cost watchdog—despite prior nods for Zolgensma and Spinraza (Fierce)
  • Organon launches ready to shop for women's health companies in biotech, medtech and more (Fierce)
  • NICE turns down GSK's IV Benlysta for systemic lupus (PharmaTimes)
  • Genmab enters oncology collaboration with Bolt Biotherapeutics (PMLive)
  • Aspen Japan to Be Renamed Sandoz Pharma in September (PharmaJapan)
  • Astellas Plans to Cut 450 Jobs via Voluntary Redundancy Program (PharmaJapan)
  • MDIC Report Looks Back At 2020 (MedtechInsight)
  • Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths (MedtechDive)
  • Medtronic Bounces Back During Quarter Four Of Financial Year 2021 As Procedure Volumes Normalize (MedtechInsight)
  • European Commission’s Eudamed Draft Implementing Regulation Tackles Problems Head On (MedtechInsight)
Government, Regulatory & Legal
  • Developments in State Prescription Drug Price Transparency Laws (FDA Law Blog)
  • Drugmakers Fire Torpedo At 'Centerpiece' Of Calif. Opioid Trial (Law360)
  • Patentees Get Boost With China's Version Of Hatch-Waxman (Law360)
  • Drugmakers Urge Fla. Court To Trim Zantac MDL (Law360)
  • Ex-Theranos CEO Can't Have Atty Privilege Via Boies Schiller (Law360)
  • FTC Can't Seek Restitution From Shkreli Until Congress Acts (Law360)
  • Pharmacist Says 8 Years Enough For Lab Outbreak Scandal (Law360)
  • Elizabeth Holmes Wants 'Anecdotal' Evidence Blocked In Trial (Law360)
  • Hearing Aid Implant Maker Mostly Wins At PTAB Against Rival (Law360)
  • Purdue Asks To Extend Opioid Suit Shield To End Of Summer (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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