India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension
Johnson & Johnson notched a loss today as India’s patent office refused to extend the patent on bedaquiline, a drug for treatment-resistant tuberculosis. The company was looking to extend the patent to 2027, but the patent office’s refusal means J&J will lose the patent by July, ending the company’s monopoly of the drug and opening the door for cheaper generics.
Cidara’s Anti-Fungal Receives Approval with Priority Review from US FDA
Rezzayo, Cidara Therapeutics’ newest anti-fungal drug, has received the nod from the US Food and Drug Administration (FDA) for approval under priority review for two kinds of candida infections, candidemia and invasive candidiasis. The drug is currently being reviewed by the EMA, which has already granted its marketing authorization approval.
Rare Skin Cancer Drug by Incyte Receives Accelerated Approval
Incyte notched a win today, March 23rd, with accelerated approval for retifanlimab, its treatment for a rare, aggressive skin cancer called Merkel cell carcinoma. The approval comes after patients single-arm study achieved a 52% response rate, with 18% seeing a complete response. These responses were durable out to almost 25 months in some patients.
Biogen’s ALS Drug Receives Unanimous Recommendation Accelerated Approval from FDA Adcomm
Tofersen, Biogen’s ALS Drug, has received a unanimous 9-0 recommendation for accelerated approval by the US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee. The move comes in spite of results from a Phase III trial in which the drug failed to meet its primary outcome of reducing disease activity from baseline at 6 months. It did, however, reduce levels of a key protein in ALS pathophysiology, which the committee believes may impart long-term benefits.
Questioning the Detrimental Impacts of QALY in Health Policy
While disability advocates and lawmakers have decried the use of quality-adjusted life years (QALY) in recent years, some argue that it is an indispensable measure that is unfairly maligned. For example, patient advocates argue that the focus on quality of life devalues the lives of disabled people and patients with chronic illness. Writers from the Center for the Evaluation of Value and Risk in Health (CEVR) contend this is a misunderstanding.
Eisai CEO Not too Worried About Leqembi After CMS Keeps Anti-Amyloid Rule
Eisai’s CEO Ivan Cheung told Fierce Pharma he is not too worried about the long-term success of Leqembi in light of the US Centers for Medicare and Medicaid Services (CMS) declined to change its rule about reimbursement for drugs in its class. The rule states that drugs targeting amyloid, a key protein in Alzheimer’s disease, can only be covered for patients in clinical trials.
Ozempic and Mounjaro Back on Shelves
Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, both diabetes drugs used off-label for weight loss, have been on a backlog for months due to an explosion of popularity. According to the US Food and Drug Administration, most doses of the two drugs are back in stock. This excludes the higher doses of Ozempic, however.
US FDA to Review Ipsen’s Rare Bone Growth Disease Therapy
The US Food and Drug Administration (FDA) has set a date to decide on Ipsen’s new drug application for its drug candidate palovarotene in the treatment of fibrodysplasia ossificans progressive (FOP), a rare disorder where extra-skeletal tissues like muscles and tendons are converted into bone tissue. This would be the first therapy for the disabling, progressive condition.
FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency extended the review period.
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s Stellara, Sanofi’s Aubagio, and Takeda’s Vyvanse.
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, Sanofi set an out-of-pocket cap of $35 a month for patients.
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put out a call for feedback. Responses are due by April 14th.
US HHS Picks 27 Drugs for Inflation Rebates
A recent rule will let the US Department of Health and Human Services (HHS) require drugmakers to pay back rebates on drugs that increase in price faster than inflation. The department has announced its list of the first 27 drugs to face this process, including therapeutics from pharma giants like Pfizer, Gilead, and AbbVie.
Which Drugmakers Will Face US Drug Pricing Negotiations in 2026?
Although many likely contenders have been named, the first slate of drugs to face Medicare drug pricing negotiations in 2026 is yet to be determined. The first 10 drugs to be selected will be announced in September, likely including cancer drugs from AbbVie and Pfizer and BMS’s blood thinner Eliquis, among others.
Pharma’s Take on Drug Pricing Data Transparency in South Korea
Korea’s drug pricing policies are complex and lack transparency, according to Eli Lilly Korea’s General Manager Christopher J. Stokes. Stokes notes that he has spent considerable time talking with other pharma leaders, who generally agree with his take on the complicated nature of the South Korean Market.
Lilly and Boehringer’s Type II Diabetes Drug Gets Expanded Approval from FDA for Use in Children
Eli Lilly and Boehringer Ingelheim secured approval from the US Food and Drug Administration (FDA) to expand the indications of its diabetes drug Jardience. The new indications include children under 10 with type 2 diabetes, a growing population in recent years. The drug would be the first in its class for patients in this age group, opening up a new avenue for early life diabetes management.
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only 22 drugs getting simultaneous review in the past five years.
New US Bill Challenges Use of QALY in Drug Value Assessments
Quality-adjusted life years (QALY) is a metric widely used when determining the cost-effectiveness of a drug, often when deciding upon or recommending drug prices. A new bill was approved by the US House Energy and Commerce Health Subcommittee that would, if passed, end the practice of using QALY in drug value-assessments. Proponents of the ban say relying on QALY undervalues the positive effects of therapeutics on people with disabilities.
Merck’s MMRV Vaccine Gets FDA Approval for Intramuscular Delivery
The US Food and Drug Administration (FDA) has cleared intramuscular administration for measles, mumps, rubella, and varicella (MMRV) vaccines from Merck. This opens up more options for care providers and marks a shift from subcutaneous injections, which were the standard for the shot. The approval covers three of Merck’s MMRV vaccines.
Wegovy Gets NICE Recommendation and Novo Nordisk Plans UK Launch
The UK’s National Institute for Health and Care Excellence (NICE) gave Novo Nordisk’s weight loss drug Wegovy its recommendation for coverage today, March 8th. In response, Novo Nordisk is making plans to bring the wildly popular drug to the UK market. However, the drug will be more tightly controlled than in the US or EU markets, where the drug has taken off with celebrities and influencers.
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another amyloid-targeted Alzheimer’s disease therapy, followed by its controversial accelerated approval.
US Court Temporarily Shoots Down J&J’s Plan to Prevent Amgen from Releasing Stelara Biosimilar
A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit seven minutes ahead of submission. Pfizer may file again with documents that match the court’s specifications.
UK Increases Statutory Scheme and VPAS Revenue Clawback Rates
The UK’s voluntary scheme for branded medicines pricing and access (VPAS) controls National Health Service (NHS) spending by requiring drugmakers to recoup the government for a portion of sales if spending exceeds a certain rate of growth. The new clawback rate for VPAS increased to 26.5% while the Statutory Scheme increased to 27.5%. As a result several pharma companies are reconsidering their strategy in the nation.
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already approved for young children as a third dose.
Potential Targets Emerge for Upcoming Medicare Price Negotiations
With Medicare negotiations beginning in 2026, some major sellers by Novo Nordisk, Eli Lilly, and Merck are likely early targets of the drug pricing reforms included in the US Inflation Reduction Act (IRA). This includes diabetes drugs like Januvia by Merck and cancer drugs like Pfizer’s Ibrance and Xtandi. However, some of the most expensive drugs in the nation are off the table.
