The first full approval for a COVID-19 vaccine has been awarded by the FDA. Pfizer and its German partner BioNTech’s vaccine, now marketed as Comirnaty, is now approved for people 16 and older. It will remain under an emergency status for adolescents aged 12 to 15.

According to multiple news outlets, the Biden administration has decided to recommend booster shots for most Americans. According to The New York Times, the endorsement could come as early as this week.

Citing impurity concerns, Sanofi has pulled hypertension medications in Korea and UK. This recall joins concerns first raised in Canada and Europe.

GSK’s Shingrix was initially approved by the FDA in October 2017 for the prevention of shingles in adults aged 50 and older. However, the pandemic and CDC’s recommendation for individuals not to get another vaccine within weeks of receiving the COVID-19 vaccine has caused many people to miss vaccinations.

AstraZeneca’s, Bydureon, has met its endpoint in a phase 3 clinical trial of people aged 10 to 17 with type 2 diabetes. The study is testing a once-weekly formulation of the glucagon-like peptide-1 receptor agonist exenatide.

Amgen has plans to spend $365 million on a new smart factory in New Albany, Ohio. This facility is expected to be the most digitally advanced of all of its locations. Construction of the new 270,000 square-foot building is to begin in the fall of 2021 and will eventually employ 400 individuals.

Thanks in part to the pandemic, a newer company measuring stick for fund investors and younger employees is the ESG accountability. This includes the environment, social, and governance categories.

PharmStars, the first and only pharma-focused accelerator for digital health startups, was founded just weeks ago and already has Boehringer Ingelheim, Eli Lilly and Takeda join their platform. PharmStars’ focus is to connect drugmakers to digital health startups.

Biogen has received FDA approval for Aduhelm, a drug used to treat Alzheimer’s treatment. In what has been one of the most closely watched green lights of the year, Aduhelm’s approval includes all Alzheimer’s patients meaning millions of potential patients may be eligible for the drug.

We are happy to announce that Staffing Industry Analysts has listed The Bandish Group in their '2021 US and Canada Diversity-Owned Staffing Firms' list.

The FDA has approved Lumakras, the first treatment for non-small cell lung cancer (NSCLC) with a particular genetic mutation called KRAS G12C.

The FDA has granted Merck the go-ahead based on initial data from its first 264 patients that are enrolled in a study that combines Keytruda with Roche’s Herceptin and chemotherapy. This treatment had tumors shrink in 74.4% of patients with newly diagnosed, HER2-positive gastric or gastroesophageal junction cancer. That is considerably more than the 51.9% for the standard-of-care Herceptin-chemo treatment.

Pfizer's Hospira is recalling one lot each of the injectable hospital anesthetics bupivacaine hydrochloride (HCL) and lidocaine HCL after an investigation into a confirmed customer report revealed that a portion of each lot was mislabeled as the other product.

Bayer continues to ramp up its cell and gene therapies expansion. This time it comes with a $200M plan to upgrade its Berkeley location with cell therapy labs. The facility is to be called the Cell Therapy Launch Facility.

Humana has had to recall nearly 200,000 bottles of extra-strength acetaminophen tablets after bottles distributed in a Health Essentials kit had an incomplete prescription drug label. The health kits were sold between January 14tha and March 15th of this year and also included hand sanitizer, face masks and cough drops.

In its closest contest to date, GlaxoSmithKline’s Dovato beat Evofem’s Phexxi to win the 2021 FierceMadness ad tournament.

GSK’s “Everything That I Am” campaign, won by just 8 votes – 1,228 to 1,220.

Fierce Pharma has ranked the top 20 drugmakers by global revenues in 2020. For the most part companies met their financial goals despite the pandemic.

Key changes from to note from 2019 are Pfizer fell 5 places as it finished its deal to spin off its Upjohn business. AbbVie moved up 3 spots due to its buy of Allergan. Lastly, after buying Celgene, BMS, moved up 4 spots.

Fierce Pharma’s Fierce Madness tournament has been narrowed down to a field of eight. The remaining ‘teams’ are Ocrevus, Phexxi, Johnson & Johnson, Adakveo, Bayer, Pfizer-BioNTech, Nurtec, and Dovato. This year’s event is focusing on each company’s DTC ad campaign.

Just weeks after the FDA approved Breyanzi, Bristol Myers Squibb’s therapy to treat CAR-T lymphoma, the company has announced plans to expand its Devens, MA location with a new 244,000 square foot cell therapy site.

Fierce Pharma, in conjunction with Evaluate consensus sales estimates, has put together a list of what expects to be the most anticipated new drug launches in 2021.