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Regulatory Focus™ > News Articles > 2021 > 7 > Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTec

Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTech vaccine in 2022

Posted 21 July 2021 | By Michael Mezher 

Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTech vaccine in 2022

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Anthem still determining coverage policy for Biogen Alzheimer's drug (Reuters)
  • Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage (Reuters)
  • Drugmakers, pharmacies next targets for US opioid settlements (Reuters)
  • Former FDA adviser calls for wider probe into Biogen Alzheimer's drug approval (Reuters)
  • J&J forecasts $2.5 bln in 2021 COVID-19 vaccine sales, sets lower production target (Reuters)
  • J&J Vaccine May Be Less Effective Against Delta, Study Suggests (NYTimes)
  • FDA rejects professor’s petition seeking to pull ‘dangerous’ Otsuka kidney disease drug (Endpoints)
  • Cash shortage threatens White House global vaccine effort (Politico)
  • PrEP, the HIV prevention pill, must now be totally free under almost all insurance plans (NBC)
  • As a key hearing nears, Justice Department calls Purdue’s bankruptcy plan unconstitutional (STAT)
In Focus: International
  • S.Africa's Biovac to start making Pfizer-BioNTech vaccine in H2 2022 – CEO (Reuters)
  • Novartis set to deliver 50 mln CureVac COVID-19 vaccines this year (Reuters)
  • Norway, Lithuania swap J&J, Pfizer vaccines to speed up inoculation (Reuters)
  • Sinopharm's COVID-19 shot induces weaker antibody responses to Delta -study (Reuters)
  • Novartis aims to beat rivals to novel $10bn cancer treatment market (FT)
  • Drugmaker Sobi profit tops forecasts, sees markets recovering (Reuters)
  • Catalent plans $100 mln expansion at vaccine plant in Italy (Reuters)
  • EU rejects UK demand for new post-Brexit deal on Northern Ireland (Reuters)
Coronavirus Pandemic
  • Global quest underway to speed COVID-19 vaccine trials (Reuters)
  • WHO chief warns that the world is going into the ‘early stages of another wave’ (CNBC)
  • US life expectancy falls to lowest level in almost 20 years due to COVID-19 -CDC (Reuters)
  • Takeda agrees to supply additional 50 mln Moderna COVID-19 vaccines to Japan (Reuters)
  • Vietnam produces first batch of Russian COVID-19 vaccine (Reuters)
  • Leaked letters show AstraZeneca vaccine commitment not as Thailand claimed (Reuters)
  • Taiwan bumps BioNTech vaccine order to 15 mln with Buddhist donation (Reuters)
Pharma & Biotech
  • How cozy is too cozy? FDA and Biogen offer up a test case (Endpoints)
  • FDA plans to study whether pharma reps at conference exhibit booths are telling the truth (STAT)
  • Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say (STAT)
  • Philip Morris CEO defends the company’s intentions to buy inhaler maker Vectura (CNBC)
  • Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too (Endpoints)
  • Myovant, Gedeon Richter’s uterine fibroids med Ryeqo bags EU approval (PharmaTimes)
  • AstraZeneca, Alexion close massive $39B merger; bluebird bio earns EU nod for Lenti-D as big split approaches (Endpoints)
  • Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy (Pink Sheet)
  • Novartis discards one of its ‘wild card’ drugs after it flops in key study. But it takes one more for the hand (Endpoints)
  • A Novartis castoff with a troubled past headlines Chinese biotech's Hong Kong IPO quest (Endpoints)
  • Albireo caps a big week with back-to-back approvals in the US/EU for the first drug to treat a severe liver disease (Endpoints)
  • FDA levels clinical hold on Magenta's second lead drug, asking for an additional bioassay before it gets to humans (Endpoints)
  • Can a next-gen take on a deadly weight loss pill conquer cardiometabolic diseases? A Medicxi-backed startup thinks so (Endpoints)
  • PacBio engineers $800M buyout of sequencing rival Omniome as analysts fret over FTC action (Endpoints)
  • As healthcare heats up on HKEX, Qiming sets up $500M fund dedicated to public companies (Endpoints)
  • The pivot: Turnstone Biologics opens a new chapter with a switch to clinical development and a new venture round to pay for it (Endpoints)
  • New study shows smaller biopharma companies struggle more than larger ones with clinical trial transparency (Endpoints)
  • On a mission to treat patients not covered by Luxturna, Horama refuels with a Series B expansion and a new name (Endpoints)
  • FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes (Press)
  • Medtech M&A expected to be robust in second half after 2021 began with a flurry (MedtechDive)
  • ‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape (Medtech Insight)
  • BD acquires needle-free blood draw company Velano Vascular for ‘one-stick’ hospital stays (Fierce)
  • Radiation therapy 'under attack' from CMS cuts, professional body warns (MedtechDive)
  • First Expert Panel Opinion Offers Valuable Learning Opportunities (MedtechInsight)
  • CMS pitches stiffening price transparency fines, halting end of inpatient-only list (MedtechDive)
  • Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target (MedtechDive)
  • Neuspera Medical scores $65M for nerve-stimulating implant to treat overactive bladder (Fierce)
Government, Regulatory & Legal
  • Examiner Clears Sacklers Of Influencing Purdue's Board (Law360)
  • Opana Sales Calls Didn't Cause Rx Rise, Economist Testifies (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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