• While one Abecma filing stalls at the FDA, Bristol Myers Squibb has received a pair of priority reviews for its other CAR-T drug, Breyanzi. 
  
  The FDA granted priority reviews to Bristol's applications for Breyanzi in previously treated follicular lymphoma and post-BTK mantle cell lymphoma. The agency's target decision dates are May 23 and May 31, respectively. 
  
  Meanwhile, another filing for Breyanzi in chronic lymphocytic leukemia or small lymphocytic lymphoma following a BTK inhibitor and BCL-2 inhibitor is progressing under a separate FDA priority review. That application carries a target action date of March 14.
   
• Eli Lilly has won approval in Canada for Olumiant as a treatment for severe alopecia areata. The drug is not recommended for use with other JAK inhibitors, biologic immunomodulators, azathioprine, cyclosporine or other potent immunosuppressants.
  
  The Lilly JAK inhibitor beat placebo in two phase 3 trials at helping patients recover hair. Across the studies at 36 weeks, 17% to 22% of patients taking Olumiant at 2 mg/day and 32% to 35% of patients taking the 4 mg/day strength achieved 80% or more scalp hair coverage. Only 3% to 5% individuals taking placebo could say that.
  
  Back in June 2022, Olumiant became the first drug specifically approved by the U.S. FDA to treat alopecia. 
   
• Following an FDA approval in September and a European Commission nod Monday, GSK's Ojjaara, or momelotinib, has moved closer to a go-ahead in Canada. Local health authorities have accepted GSK's application for the JAK inhibitor as a myelofibrosis treatment.
  
  An estimated 1,400 to 2,177 patients are living with myelofibrosis in Canada, according to GSK. Globally, about 82% of myelofibrosis patients are diagnosed with intermediate or high-risk disease, and about one-third to one-half of patients are anemic at the time of diagnosis.
   

UPDATED: Monday, Jan. 29 at 1:15 p.m. ET

• Partners AstraZeneca and Daiichi Sankyo announced that a label expansion filing for their antibody-drug conjugate Enhertu has gained an FDA priority review.
  
  The filing seeks FDA approval for the drug to treat certain patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment or who have no satisfactory alternative treatments.
  
  The partners' tumor-agnostic application leverages data from the DESTINY-PanTumor02 trial, which showed that Enhertu was associated with "clinically meaningful and durable responses" in patients with various solid tumor types, according to the companies.
  
  AZ and Daiichi Sankyo expect the FDA's decision on their filing in the second quarter of 2024.
   
• Drugs in Takeda's immune globulin franchise have gained expanded approvals on opposite sides of the Atlantic.
  
  In the U.S., the FDA approved Gammagard Liquid to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The drug is an immune globulin infusion that comes without the human enzyme hyaluronidase. Under the new label, Gammagard Liquid can be used as an induction therapy, Takeda said in a Monday release.
  
  The expanded FDA nod follows a recent approval for Takeda's Hyqvia, an immune globulin infusion with hyaluronidase, as a CIDP maintenance therapy for U.S. patients.
  
  “Together with the recent Hyqvia approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs," Richard Ascroft, head of Takeda’s U.S. plasma-derived therapies unit, said in a statement.
  
  As for Hyqvia, that treatment just gained European Commission approval as a maintenance therapy to treat patients with CIDP after stabilization with intravenous immunoglobulin therapy (IVIG), Takeda said Monday.
   
• Also in Europe, GSK's Omjjara won its official approval from the European Commission.
  
  The drug is approved to treat enlarged spleens and related symptoms in adult myelofibrosis patients with moderate to severe anemia. Omjjara, also known as momelotinib, is the first drug specifically approved for this use in Europe, GSK said in a release.
  
  "The availability of a single therapy for key manifestations of myelofibrosis is a clear step forward for eligible patients," Francesca Palandri, M.D., Ph.D., of the Italian hospital Policlinico Sant'Orsola-Malpighi, said in a statement.
   
• Meanwhile, GSK's label expansion bid for RSV vaccine Arexvy is moving ahead in Europe. 
  
  The European Medicines Agency has accepted the company's application for Arexvy as an RSV prophylactic for people 50 to 59, GSK said. 
  
  Last year, European officials approved the vaccine for the prevention of lower respiratory tract disease caused by RSV in people 60 and older.
  
  GSK expects a decision on its new filing during the second half of this year.

UPDATED: Thursday, Jan. 25 at 1:30 p.m. ET

• Heron Therapeutics scored a label expansion for its extended-release local anesthetic, Zynrelef, (bupivacaine and meloxicam) to include soft tissue and orthopedic surgical procedures. The new FDA approval covers foot and ankle procedures, plus other operations in which direct exposure to articular cartilage is avoided, the company said in a press release.

  According to Heron, Zynrelef is the only therapy for post-surgery pain management that’s demonstrated superiority to the current standard of care, bupivacaine, in late-stage trials.

  With an expanded approval in hand, Heron expects Zynrelef will be eligible for use in an estimated 13 million U.S. procedures per year, an increase of 86% over prior indicated procedures. To nab its new approval, Heron ran tests studying the med's use in cesarean section, spinal surgery, augmentation mammoplasty and total shoulder arthroplasty procedures.

  Zynrelef won its initial FDA approval in May 2021.

• Meanwhile, North Carolina’s Liquidia Corporation will have to wait a while longer to clinch an approval for its Yutrepia inhalation powder in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Thursday, the FDA told the company it was “confirming the process for adding the PH-ILD indication as an amendment" to Yutrepia’s drug application, meaning the agency will miss its previously stated action date of Jan. 24.

  Back in late 2021, the FDA granted Yutrepia a tentative approval to treat PAH to improve exercise ability in adult patients with certain symptoms. Seeking to add PH-ILD to Yutrepia’s label, Liquidia filed an amendment to its drug application in July 2023.

  The FDA previously said Yutrepia could potentially add PH-ILD to its label without additional clinical trials.
   

UPDATED: Tuesday, Jan. 23 at 9:45 a.m.

• The FDA has missed its Jan. 22 target decision date for Theratechnologies' new formulation of lipodystrophy drug Egrifta (tesamorelin).
  
  Theratechnologies said it has shown that its F8 formulation of tesamorelin is bioequivalent to the original F1 formulation, which is no longer available in the U.S. The company currently offers Egrifta SV, or an F4 formulation, which itself has shown bioequivalence to F1. 
  
  Compared with the F4 formulation, F8 tesamorelin is two times more concentrated, therefore requiring a smaller volume of administration. The new version comes in a multi-dose vial that can be reconstituted once per week.
  
  The company said it will provide further information on the filing "in due course."
   
• In India, AstraZeneca has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market andexanet alfa, Financial Express reports.
  
  The drug, marketed in the U.S. as Andexxa, treats life-threatening or uncontrolled bleeding in patients who have received a Factor Xa inhibitor.
   

UPDATED: Thursday, Jan. 18 at 9:55 a.m.

• Roche's Tecentriq SC, the subcutaneous version of the company's blockbuster PD-L1 cancer therapy, has secured its first approval in Europe.
  
  The European Commission approved the drug to treat certain patients with urothelial carcinoma, lung cancer, breast cancer and hepatocellular carcinoma. With the nod, Tecentriq SC becomes the first subcutaneous PD-1 or PD-L1 cancer medicine available in Europe, Roche said in a release.
  
  More than 38,000 patients received the original, intravenous version of the drug in Europe last year. The IV approach takes 30 to 60 minutes, while the under-the-skin subcutaneous injection takes around five minutes, according to Roche.
  
  Roche notes that the subcutaneous route of administration "offers the potential for a faster, more convenient alternative" to an intravenous infusion. The subcutaneous approach is "preferred by cancer patients, nurses and physicians," according to the Swiss drugmaker.
   
• In the United Kingdom, Santhera's Agramree has picked up approval to treat patients 4 and older with Duchenne muscular dystrophy.
  
  The U.K.'s Medicines and Healthcare products Regulatory Agency adopted the view of the European Medicines Agency and recognized the drug's "clinically important safety benefits" over standard of care corticosteroids, plus its "similar efficacy," the company said in a release.
  
  The nod follows approvals for the drug in Europe and the U.S.
  
  European launches are progressing this quarter, Santhera said in the release, with Germany expected to be out ahead of other countries.
   

UPDATED: Thursday, Jan. 11 at 10:00 a.m.

• China's National Medical Products Administration has approved GSK's Nucala as an add-on maintenance treatment for patients with severe eosinophilic asthma who are 12 years of age and older.
  
  With the nod, Nucala becomes the first targeted IL-5 biologic approved in China in this indication, GSK said in a release.
  
  The approval is based on a China-only, 52-week phase 3 trial. The study found that patients who received GSK's drug experienced 65% fewer clinically significant exacerbations than those who received placebo.
  
  In 2021, GSK's drug won approval in China to treat eosinophilic granulomatosis with polyangiitis.
   
• Mirati Therapeutics' KRAS-targeted therapy Krazati has won an approval in Europe to treat adults with KRASG12C-mutated advanced non-small cell lung cancer who've experienced disease progression after at least one prior systemic treatment.
  
  In a registration-enabling phase 2 study, the drug met its endpoints of objective response rate and duration of response, the biotech said in its release.
  
  The European Commission's conditional approval decision follows a positive recommendation from the Committee for Medicinal Products for Human Use in November 2023.
  
  Meanwhile, Mirati is in the process of being bought out by Bristol Myers Squibb.
   
• Also in Europe, Stada and Alvotech have won regulatory clearance for the first biosimilar of Johnson & Johnson's Stelara.
  
  Following a patent expiration in July, the approval "paves way for biosimilar competition in the approximately €2.5 billion" Stelara market in Europe, according to the partners.
  
  In the U.S., Johnson's blockbuster immunology drug is expected to face competition early next year.

UPDATED: Tuesday, Jan. 9 at 2:45 p.m.

• Pfizer's PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas' Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  
  This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release.
  
  The European Commission approved Pfizer's application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi.
  
  Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC.
   
• In another regulatory win for Pfizer, the FDA is reviewing the company's full approval application on Genmab-partnered Tivdak.
  
  Under its priority review timeline, the FDA is assessing whether to convert Tivdak's accelerated approval into a full nod to treat patients with recurrent or metastatic cervical cancer who've had disease progression on or after first-line therapy.
  
  The FDA plans to act on the filing by May 9, Pfizer said.
   
• Eisai and Biogen's Alzheimer's disease drug Leqembi has picked up an approval in China to treat patients with mild disease. 
  
  Eisai estimates there will be 17 million patients in China in 2024 who could be eligible for Leqembi based on the med's current label. And the med's popularity is expected to grow as the population ages.
  
  "Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment," the company said.
   
• Amid Sarepta's early launch of Duchenne muscular dystrophy gene therapy Elevidys, the company is aiming for a significant label expansion.
  
  In an update (PDF) at the J.P. Morgan Healthcare Conference, Sarepta argued that late-stage clinical data on the medicine "exceeded the threshold for substantial evidence of effectiveness" and that the drug's risk/benefit profile "remains favorable." Sarepta is expecting a decision by the FDA on its expansion bid by August, the company said.
  
  Elevidys won an accelerated FDA approval back in June to treat ambulatory DMD patients ages 4 to 5 years with a confirmed mutation in the DMD gene. After that accelerated approval and subsequent trial results, the company is pursuing an FDA nod to treat all patients.
  
  This week, analysts with Mizuho said they "believe the odds are high for the label expansion," according to Investing.com.

UPDATED: Friday, Jan. 5 at 9:35 a.m.

• After last year's approval from the U.S. FDA, Pfizer's RSV vaccine Abrysvo has secured an approval from Health Canada.
  
  Regulators in Canada endorsed the vaccine for use in adults 60 years of age and older to prevent lower respiratory tract disease caused by RSV. In addition, the agency signed off on the vaccine's use in people who are between 32 and 36 weeks pregnant to protect their infants after they're born.
  
  Canada's National Advisory Committee on Immunization is conducting its own review of the vaccine and will issue guidelines around using the vaccine in Canada.
  
  GSK's Arexvy is also approved in Canada for use in people 60 and older.
   
• Ultragenyx's Evkeeza has picked up a coverage recommendation in England.
  
  The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending the medicine, plus diet and other LDL-C therapies, for the treatment of adults and children 12 and older with homozygous familial hypercholesterolemia (HoFH).
  
  Ultragenyx points out that the drug is the first angiopoietin-like 3 inhibitor for the disease.
  
  In 2022, the company inked a deal with the drug's developer, Regeneron, to commercialize Evkeeza outside the U.S.

UPDATED: Wednesday, Jan. 3 at 9:30 a.m.

• After two decades of stagnation, the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has welcomed a new endocrine therapy into the cancer fighting fold. 
  
  Now dubbed Korserdu, Menarini Group's small molecule drug has been cleared in the U.K. as the first medicine to treat ER+, HER2- advanced or metastatic breast cancer tumors with ESR1 mutations. The drug is specifically authorized for postmenopausal women and men who've already tried at least one line of endocrine therapy, including a CDK 4/6 inhibitor.
  
  ESR1 mutations are acquired mutations that develop from exposure to endocrine therapy, which drive resistance to standard endocrine therapy. 
  
  Korserdu helped patients with ESR1 mutations hit a median progression-free survival of 3.8 months versus 1.9 months for those on standard of care. The treatment also reduced the risk of progression or death by 45% compared to standard of care.
  
  Korserdu's U.K. green light comes several months after the medicine won marketing authorization in the European Union under the brand name Orserdu.
   
• Elsewhere, the European Medicines Agency (EMA) accepted Bristol Myers Squibb's application for potential approval of its next-generation tyrosine kinase inhibitor (TKI) repotrectinib. The drug is angling for approval in locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors. 
  
  BMS girded its application with data from the phase 1/2 Trident-1 trial, as well as the pediatric Care study. The clutch of clinical trials shows repotrectinib charted clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts.
  
  Back in November, the U.S. FDA approved repotrectinib as Augtyro to treat adult patients with locally advanced or metastatic ROS1-positive NSCLC.
   
• Speaking of the FDA, the U.S. drug regulator late last month approved Coherus BioSciences' Udenyca Onbody delivery system for its biosimilar to Amgen's febrile neutropenia drug Neulasta. 
  
  Coherus' copycat, dubbed Udenyca, is given to patients the day after chemotherapy to curb infections caused by febrile neutropenia. 
  
  The company's Onbody delivery system tees up administration of pegfilgrastim in just five minutes. The delivery system also features an indicator and status light, plus an audio signal that helps patients confirm the dose has been administered.
  
  Coherus expects to make its Udenyca Onbody delivery system available in the U.S. during 2024's first quarter.