If 2020 underscored the importance of the pharma industry’s social importance, 2021 demonstrated the industry’s ability to translate R&D into profitable commercialized products. But while strong demand for COVID-19 therapies in 2021 provided unprecedented revenue levels for a handful of Big Pharma companies, it didn’t result in substantial changes in R&D spending. (Look out for…
50 of 2021’s best-selling pharmaceuticals
Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for…
Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer
Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN). Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer. The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
Molnupiravir holds up to omicron in lab studies
Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro. The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the…
COVID-19 oral antiviral molnupiravir wins FDA nod
Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801). In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir. FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir). FDA’s authorization of…
Pfizer’s COVID-19 antiviral pill could be poised for European regulatory authorization
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid. CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease. CHMP also stressed the…
Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list
A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek. The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall…
FDA advisory committee votes in favor of COVID-19 pill molnupiravir
FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks. A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions. FDA generally follows the advice of its advisory committees. “This was clearly…
FDA advisory panel to weigh in on molnupiravir
An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…
Pfizer to make COVID-19 pill available in low- and middle-income nations
In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world. Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir. Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to…
U.S. to buy 1.4 million additional courses of molnupiravir
Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir. One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion. The U.S. has committed to buy approximately 3.1…
UK approves Merck’s oral COVID-19 drug molnupiravir
The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the drug in Great Britain. Furthermore, it has allowed emergency use authorization of the drug for Northern Ireland. MHRA recommends that…
Merck projects at least $5B in 2022 sales for molnupiravir
Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected. Sales of the drug could be higher, assuming it finds widespread use in wealthy countries. Merck expects sales between $500 million and $1 billion…
EMA begins rolling review of Merck’s and Ridgeback’s COVID-19 pill molnupiravir
Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market. Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA. The…
ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older
CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy. CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins…
A course of Merck’s COVID-19 pill could cost more than $700
Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization. The medicine could also be lucrative for Merck, assuming it finds widespread use. Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than…
Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy
The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals…
Merck picks up Acceleron for $11.5B
Merck (NYSE:MRK) has agreed to acquire the biopharma Acceleron Pharma (NSDQ:XLRN) for $180 per share in cash, bringing the purchase price to roughly $11.5 billion. The companies expect the deal to close in the fourth quarter of 2021. Cambridge, Massachusetts–based Acceleron specializes in developing drugs that aim to balance transforming growth factor (TGF)-beta, which plays…
Lilly wins Erbitux label expansion for colorectal cancer indication
FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test. The indication covers previously-treated patients. Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor…
Merck and Vesselon preclinical study reports dramatic tumor pharmacokinetics findings
Merck & Co. (NSDQ:MRNA) scientists have explored fighting cancer by way of the STING (stimulator of interferon genes)-controlled innate immune pathway. Now, the company has published research in Advanced Therapeutics detailing a preclinical study with its partner Vesselon Inc. that reported impressive pharmacokinetics results related to MSA-1, a STING agonist. The researchers found that low…
Hookipa Pharma announces oncology partnership with Merck
Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC). Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.…
FDA approves Merck’s Keytruda to treat certain types of breast cancer
Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC). Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based…
34 of the most innovative pharmaceutical products
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
RECARBRIO effective against gram-negative microorganisms
FDA has indicated Merck‘s Recarbio for infections resulting from susceptible gram-negative microorganisms. The drug combines imipenem (a penem antibacterial), cilastatin (a renal dehydropeptidase inhibitor) and relebactam (a beta-lactamase inhibitor). Current FDA indications for the drug include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, complicated urinary tract infections and complicated intra-abdominal infections.