Pfizer Inc has submitted a application to the FDA for the approval of Paxlovid, which is intended to treat patients at high risk for progression to severe illness from COVID-19. Currently, Paxlovid is authorized for emergency use for mild-to-moderate COVID-19 in adults and pediatric patients at high risk for progression to severe COVID-19. The submission includes non-clinical and clinical...

Pfizer Inc. reported its fourth quarter earnings that surpassed expectations. The biotech company’s adjusted earnings for the three months ending in December surged +157% from the year-ago quarter to $1.08 per share, beating the Street consensus forecast of 87 cents. Revenues rose +104% year-over-year to $23.8 billion, compared to analysts' estimates of $24.1 billion. Looking ahead, Pfizer...

Pfizer Inc. and BioNTech got approval from The Food and Drug Administration (FDA) for authorizing Covid booster shots in children aged 12 to 15. This is an emergency use authorization, amid omicron variant spread. The FDA also narrowed the time for administration of a booster dose from at least six months to at least five months following completion of the primary series for people 12 and...

Biogen shares took a hit, after Samsung BioLogics denied a report that claimed that it's discussing takeover plans that at a value of around $42 billon. Korea Economic Daily report mentioned ties between the two groups including FDA approval of key treatments, as well as Biogen's 50% stake minus one share in biosimilars unit Samsung Bioepis Co. The report also stated plans from the Samsung...

Pfizer said final analysis of its antiviral Covid-19 pill reveals almost 90% efficacy in preventing hospitalizations and deaths among high-risk patients. In a final study data, Pfizer said its Paxlovid treatment remained 89% effective in preventing hospitalizations in high-risk unvaccinated people when used within three days of the appearance of symptoms. However, a separate study suggested...

Bristol-Myers Squibb increased its quarterly dividend and added $15 billion to its buyback program. The pharmaceutical company’s third quarter earnings came in at $2 per share. It boosted its dividend by 10.2%, to 54 cents per share, while taking its total share buyback program to $15.2 billion. The company now expects its fiscal 2022 dividend to rise to $2.16 per share, which would be the...

Pfizer and partner BioNTech are going to seek the approval of the U.S. Food and Drug Administration possibly this week to expand Covid-19 booster shot eligibility to 16- and 17-year-olds. Currently, 18 and older are eligible for booster shots six months after receiving the second shot of the Pfizer-BioNTech or Moderna vaccine. According to the Washington Post, the regulators are expected to...

Pfizer Inc. and partner BioNTech said that a trial of their Covid vaccine booster was 95.6% effective. According to the biotech companies, the results were based on a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech Covid-19 vaccine in more than 10,000 individuals 16 years of age and older. “In the trial, a booster dose...

Pfizer Inc. said that results from its Covid-19 vaccine’s late-stage trial involving young children showed a "favorable safety profile and robust neutralizing antibody responses." The pharmaceutical company said that a 10 µg dose given to children between the ages of 5 and 11 (which is around a third of that given to older children and young adults in similar testing) produced comparable...

Gilead Sciences’ quarterly adjusted earnings came in at $1.87 per share for the quarter ended June, surpassing Zacks Consensus Estimate of $1.76 per share.It was $1.11 per share in the year-ago quarter.

The biopharma company has exceeded consensus EPS estimates four times over the last four quarters.

Gilead’s revenues were $6.22 billion, beating the Zacks Consensus Estimate by 1.14%.

According to the Committee, the benefits outweighed the risks of a rare blood-clot condition.

But the Committee voted 10 to 4 with one abstention to advise the U.S. Food and Drug Administration (FDA) and the CDC to resume use of the vaccine without any conditions.

The J&J vaccine use was put on hold last week, following reports of rare blood-clot conditions in six people, including one fatality.Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, had expected that the U.S. use of the vaccine would resume as soon as Friday, perhaps with new restrictions.

However, the FDA is expected to include label warning on the J&J vaccine to women under the age of 50.

Bristol-Myers Squibb  got  approval for Opdivo as a treatment for gastric cancer from the Food and Drug Administration (FDA).

Opdivo as an injection combined with chemotherapy to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.FDA’s approval is based on a Phase 3 trial.

As demonstrated in the … trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma,”said Adam Lenkowsky, general manager of oncology at the company.

Earlier this week, Truist boosted rating on the pharmaceutical company’s shares to buy from hold, citing optimism about its drug pipeline.

Gilbert also raised his price target to $74 a share from $66. 

“We launched on U.S. major [pharmaceuticals] in October with an overall bullish view on the group, but we started with a hold rating on BMY pending greater visibility on key late-stage pipeline assets,” Gilbert wrote in a commentary.Since then, BMY has received regulatory approval for Abecma (ide-cel) and Breyanzi (liso-cel), and announced positive top-line Phase 3 results for deucravacitinib (TYK2 inhibitor) and relatlimab (LAG-3 inhibitor), Gilbert mentioned.

Gilbert cited pipeline progress coupled with results from detailed pipeline analysis as factors behind the rating boost.

The coronavirus vaccine developed by AstraZeneca PLC has been linked to an autoimmune reaction that can lead to deadly blood clots in rare instances, according to a study by researchers in Norway and Germany. According to the researchers in Norway and Germany, the vaccine could trigger an autoimmune reaction that causes blood to clot in the brain, the Wall Street Journal reported. The...

Biopharmaceutical company Amgen agreed to buy Five Prime Therapeutics in a cash deal valued at $1.9 billion. Amgen will pay $38.00 in cash for each outstanding Five Prime share. This implies a 78.7% premium to Wednesday's stock closing price. The deal is expected to close in the second quarter of 2021, subject to antitrust clearance and approval by Five Prime shareholders. Five Prime...

Biogen posted fourth quarter adjusted earnings of $4.58 a share, which is lower than Bloomberg analyst consensus forecast of $4.80. The biotech company’s revenue for the quarter fell -22% year-over-year to $2.85 billion. The analyst consensus was $2.8 billion. Biogen’s guidance on net income of $17 to $18.50 a share for this year is below the average analyst forecast of $25.09 (according to...

On Friday, Johnson & Johnson Inc. said that its developing coronavirus vaccine has a 72% efficacy rate in U.S. trials, a lower-than-expected result. It had an overall/global efficacy rate of 66% in the 44,000 person study of patients with moderate to severe forms of COVID-19. J&J’s one-shot vaccine doesn't require excessively low temperatures to store. The trial also revealed an 85% rate of...

Stocks like Moderna and Novovax have enjoyed sharp rallies in the swirl of coverage about Covid-19 vaccines. Missing from the action to date has been Johnson & Johnson, which has quietly developed another messenger RNA vaccine to join those already approved and in circulation. Johnson & Johnson's vaccine only requires one shot, which could make it easier to distribute in large quantities,...

After Pfizer Inc. coronavirus vaccine  got a positive review  from a panel of experts advising the Food & Drug Administration, the pharma company increased its quarterly dividend.  Yesterday, a 17-4 vote endorsed the covid-19 vaccine jointly developed by Pfizer and BioNTech. The FDA will move ahead with its Emergency Use Authorization approval later today. Pfizer announced that it would pay out a first quarter dividend of 39 cents per share, which is +3% higher than its previous level.  “Our commitment to returning capital to shareholders is strong and the dividend increase reflects our continued confidence in the business and in our scientific pipeline,” said CEO Albert Bourla.

The report comes ahead of its Thursday assessment of the Emergency Use Authorization (EUA) request filed by Pfizer last month. According to the FDA, individuals infected with COVID 19 could benefit from the Pfizer vaccine. .It has not noted any specific concerns from the late-stage trials. Last month, Pfizer said that the vaccine, called BNT162b2, had a 95% efficacy rate across all age and race demographics.