Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin receptor antagonist (ERA), it effectively blocks the binding of ET-1 to both ET A and ET B receptors. The drug has a low likelihood of interacting with other medications and its mechanism of action is well-suited for treating resistant hypertension. In clinical trials, aprocitentan demonstrated better blood pressure reduction than placebo, with the effects lasting up to week 40, and was generally well-tolerated by patients. (Text continues beneath th…
Pfizer and BioNTech secure FDA nod for omicron-adapted COVID-19 booster for kids under 5
COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age.
The booster can be administered at least two months after completing the primary vaccination series with three doses of the original Pfizer-BioNTech COVID-19 vaccine. Additionally, FDA has authorized the bivalent vaccine for use as the third dose in a primary series for the same age group. The agency, however, has not yet authorized a fourth booster dose.Trial data Supports bivalent vaccine safety and efficacy
The EUA is based on data from substudies within the companies’ Phase 1/2/3 trial (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth bivalent vaccine dose in 300 children aged 6 months to 4 years. A subset of 60 study participants within the same age group demonst…
Emory and Pfizer partner to develop new COVID-19 treatments
Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution.
Although the threat of COVID has waned over the past year, the virus remains a leading cause of death. CDC data shows 1,862 COVID-related deaths in the U.S.
Pfizer, the developer of Paxlovid and collaborator with BioNTech (Nasdaq:BNTX) on the Comirnaty COVID-19 vaccine, is arguably the most visible COVID drug developer.
For Pfizer, this partnership represents an opportunity to maintain its leadership position in the COVID-19 drug market and potentially increase revenue. The company, however, expects its revenue to slide by as much as one-third this year as a result of ebbi…
Prominent pharma M&A deals to watch in Q1 2023: Pfizer, Sanofi and others on the hunt
New York City–based Pfizer has recently been on a shopping spree, scooping up Trillium Therapeutics, Biohaven, Global Blood Therapeutics, and Arena Pharmaceuticals. Now, the company has unveiled its plans to acquire Seagen (Nasdaq:SGEN), a Seattle biotech firm focused on oncology. The proposed acquisition, valued at $43 billion, awaits regulatory approval. Pfizer plans to offer $229 per share…
Pfizer to acquire Seagen for $43B
Pfizer and Seagen announced today that they entered into an agreement under which Pfizer acquires Seagen for $43 billion.
The price of the acquisition comes to $229 in cash per Seagen share, totaling $43 billion. Both companies’ boards unanimously approved the transaction.
Seagen develops antibody-drug conjugate (ADC) technology. Four of the 12 total FDA-approved and marketed ADCs use its technology industry-wide, according to a news release.
“Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Pfizer chair and CEO. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise. Oncology continues to be the large…
Pfizer considers bolstering its oncology standing through $30B Seagen acquisition
Big Pharma giant Pfizer (NYSE:PFE) is reportedly in talks to acquire Seagen (Nasdaq:SGEN).
Founded in 1998, Seagen — formerly known as Seattle Genetics — helped pioneer a cancer therapy known as antibody drug conjugates that work like a guided missile attacking tumors with toxic agents.
Last year, Segan installed David Epstein as its CEO after its co-founder and former leader Clay Siegall resigned after an arrest.
In 2022, Seagen raked in almost $2 billion in revenue, which equated to an almost a quarter increase over the prior year.
Seagen has a market value of some $30 billion. An acquisition would likely command a premium over that figure, according to The Wall Street Journal.
Pfizer isn’t the first company with recent plans to acquire Seagen. In 2022, executives at Seagen were considering talks with Merck & Co. (NYSE:MRK) over a proposed $40 billion acquisition deal. Those talks, however, fell apart.
FDA approves Pfizer’s Cibinqo for adolescent atopic dermatitis
Pfizer (NYSE:PFE) has announced that the FDA has approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) for moderate-to-severe atopic dermatitis. The approval expands the indication for the drug, which was previously only approved for adults with the skin condition in early 2022.
The expanded indication includes adolescents between the ages of 12 and 18 whose disease is not adequately controlled with other systemic drugs or when their use is inadvisable.Cibinqo is a potential blockbuster
In 2020, Pfizer had estimated that abrocitinib would eventually garner $3 billion in peak annual sales.
The company is also investigating its potential in prurigo nodularis and pruritus.
The systemic JAK inhibitor is in the same class as baricitinib from Incyte and Lilly and upadacitinib from AbbVie.
The FDA updated the prescribing information for Cibinqo to include data from the JADE TEEN clinical trial, which evaluated the 100 mg…
Pfizer seeks EUA for omicron booster for under-5 kids
Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5.
The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.
The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.
If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.
Pfizer and BioNTech are seeking a sim…
Pfizer to invest billions in plants in Europe
Pharma giant Pfizer (NYSE:PFE) plans to spend more than $2.5 billion in facilities in Belgium and Ireland as it looks to diversify its product portfolio, according to Reuters.
In 2021, Pfizer generated $36.9 billion in sales from the Comirnaty COVID-19 vaccine. The company projects its COVID-19 vaccine to rake in $34 billion in 2022, but COVID-related sales will likely steadily fall in the coming years.
For now, the company is flush with cash. Expecting to top $100 billion in revenue in 2022, the company generated $81.2 billion last year. The company has used the funds to acquire a string of companies, including Reviral, Arena Pharmaceuticals, Biohaven Pharmaceuticals and Global Blood Therapeutics.
Pfizer will invest €1.2 billion ($1.26 billion) to upgrade and invest in a plant in Puurs, Belgium. It will spend the same sum on upgrading a plant in Dublin.
The Puurs site and a facility in Kalamazoo are pivotal sites for producing the COVID-19 vaccin…
FDA grants breakthrough therapy designation to Pfizer’s elranatamab for multiple myeloma
The investigational bispecfic antibody elranatamab has won breakthrough therapy designation from the FDA for relapsed or refractory multiple myeloma (RRMM).
Also known as PF-06863135, erlanatamab is a B-cell maturation antigen (BCMA)-targeted T-cell redirecting immunotherapy. BCMA is highly expressed on the surface of multiple myeloma (MM) cells. Elranatamab is also designed to target the CD3 receptor on the surface of T-cells to destroy myeloma cells.
Pfizer is developing elranatamab for subcutaneous use, which it believes could reduce adverse effects from the drug candidate such as cytokine release syndrome (CRS) while also offering improved convenience over IV infusions.
FDA previously granted fast track designation to the drug candidate to accelerate its rapid development and regulatory review.
To date, Pfizer has won twelve breakthrough therapy designations from FDA in oncology.
FDA’s decision to grant breakthrough therapy designation …
Pfizer reports positive data from RSV vaccine candidate trial
Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate.
The MATISSE (Maternal Immunization Study for Safety and Efficacy) investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease after birth. It met the success criterion for one of two primary endpoints.
Observed efficacy for severe medically attended lower respiratory tract illness (MA-LRTI) came in at 81% through the first 90 days of life in a pre-planned interim efficacy analysis. The study demonstrated substantial efficacy of 69.4% for infants over the six-month follow-up period. Although the second primary endpoint’s success criterion wasn’t met, Pfizer observed clinically meaningful efficacy of 57.1% through the first 90 days of life.MA-LRTI measured at 51.3% over the six-mon…
Pfizer beats The Street in Q3, raises guidance
Pfizer (NYSE:PFE) shares ticked up before hours on third-quarter results that topped the consensus forecast.
Shares of PFE ticked up 3.7% at $48.29 apiece before the market opened today.
The New York-based pharmaceutical giant posted profits of $8.6 billion. That amounts to $1.51 per share on sales of $22.6 billion for the three months ended Sept. 30, 2022.
Pfizer reported a 5.8% bottom-line gain despite a sales decline of 5.8%.
Adjusted to exclude one-time items, earnings per share came in at $1.78. That registers 39¢ ahead of Wall Street. Pfizer posted a sales beat, too, as analysts expected revenues of $21 billion.
“I continue to be proud of our colleagues’ excellence, ingenuity and unwavering commitment to bringing breakthroughs to patients,” said Pfizer Chair and CEO Albert Bourla. “Over the next 18 months, we expect to have up to 19 new products or indications in the market – including the five for which we have already be…