Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
US Food and Drug Administration approvals dominated much of the news last week. Among these was the FDA’s approval of Regeneron’s Libtayo, marking the firm’s entry into the immuno-oncology sector. The FDA also cleared for marketing: Pfizer’s Vizimpro for a rare form of lung cancer; Paratek’s antibiotic Nuzyra and acne drug Seysara; and Roche’s hemophilia A drug Hemlibra in a much wider patient population, so boding well for the Swiss pharma giant’s moves to expand out of its core oncology franchise that is facing copycat competition. On the deal-making front, there was the unexpected news that Janssen is pulling out of its agreement with Aduro Biotech on cancer drug candidates. 7 October 2018
Biotechnology
A month after the UK's National Health Service (NHS) agreed a deal to make Novartis’ Kymriah (axicabtagene ciloleucel) available to children and young people with a rare form of leukemia, a deal has been announced to bring another CAR-T therapy to English patients. 5 October 2018
Pharmaceutical
According to a new report by IQVIA Institute for Human Data Science, more and more patients are asked to pay high cost sharing due to changes in benefit design. 5 October 2018
Pharmaceutical
At its monthly meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded a referral and confirmed its advice in the context of a safety signal evaluation. More information on all safety referrals currently under evaluation is provided in the table below. 5 October 2018
Biotechnology
US biotech bluebird bio has had its marketing authorization application accepted by the European Medicines Agency for its investigational LentiGlobin gene therapy for treatment of adults and adolescents with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. 5 October 2018
Pharmaceutical
The pharmaceutical sector could be one of the worst affected by a no-deal Brexit, with interruptions to medicine imports and supply chain products putting at risk patients’ health in the short-term at least. 5 October 2018
Pharmaceutical
At its October 4, 2018, meeting in London, the Management Board of the European Medicines Agency heard an update on the Agency’s activities in the first half of 2018. 5 October 2018
Biotechnology
There was good news for Roche with the coveted wider indication for its hemophilia drug in the USA, so increasing its focus on diseases beyond cancer to help replace revenue from older products that have, or will soon, lost patent exclusivity. 5 October 2018
Biosimilars
Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff, provides commentary on the US Food and Drug Administration's Biosimilars Action Plan in an Expert View piece. 4 October 2018
Biotechnology
UK-based biotech firm Orchard Therapeutics has been awarded the fast track PRIME Designation from the European regulator for its investigational gene therapy OTL-300. 4 October 2018
Biotechnology
The Australian government has announced that it will make a drug for severe inflammatory spinal arthritis more affordable when it is listed on the Pharmaceutical Benefits Scheme (PBS), saving patients more than A$15,000 ($10,870) a year. 4 October 2018
Pharmaceutical
US biopharma firm Paratek Pharmaceuticals (Nasdaq: PRTK) was on the receiving end of good news yesterday, as the US Food and Drug Administration approved its acne drug Seysara (sarecycline). 4 October 2018
Pharmaceutical
At Wednesday’s Plenary session, the European Parliament adopted the Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA). 4 October 2018
Pharmaceutical
The Russian watchdog the Federal Anti-Monopoly Service (FAS) suspects the Bristol-Myers Squibb (NYSE: BMY) had participated in a cartel agreement during the conduct of state tenders for the purchases of drugs for state needs last year, reports The Pharma Letter’s local correspondent. 3 October 2018
Pharmaceutical
Shares of Clovis Oncology shot up 7.7% to $31.39 by close of trading Tuesday, after the company revealed that the US Food and Drug Administration had granted another Breakthrough Therapy designation for its already marketed Rubraca (rucaparib). 3 October 2018
Generics
Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA) and the man with the plan to increase competition in his country’s pharmaceuticals market, has announced a new prong to the agency’s attempts to stop ‘gaming’ of the generic drug approval process. 3 October 2018
Pharmaceutical
Following a positive recommendation from its Antimicrobial Drug Discovery Committee in August, the US Food and Drug Administration has now approved Nuzyra (omadacycline). 3 October 2018
Pharmaceutical
Even as three contaminated batches of vaccines have been found with polio type 2 virus in India, a strain that has been eradicated worldwide including India, the Health Ministry has set up a three-member committee to probe if the virus, which was officially eradicated in India in March 2014, has resurrected. The incident has again turned the spotlight on the slipshod pharma quality control procedures in India, reports The Pharma Letter’s India correspondent. 2 October 2018
Pharmaceutical
A year after being rejected by the US Food and Drug Administration (FDA), New Jersey-based Antares Pharma has been given the green light by the regulator to market its Xyosted (testosterone enanthate) injection in the USA. 2 October 2018
Generics
The pharmaceutical intellectual property aspects of the United States-Mexico-Canada Agreement (USMCA), which was agreed on Monday to replace the former North American Free Trade Agreement (NAFTA) accord, have come in for criticism from the Canadian Generic Pharmaceutical Association (CGPA). 2 October 2018
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