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
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
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
Generics
The tough times keep coming for Teva Pharmaceutical Industries. 13 February 2018
Pharmaceutical
On Friday, the US Council of Economic Advisers (CEA) released a report on how the government can help to effectively reduce the prices of lifesaving drugs while stimulating innovation in the pharmaceutical industry. 12 February 2018
Biotechnology
In a reversal of the medicines cost-effectiveness watchdog for England and Wales’ initial Appraisal Consultation Document, the National Institute for Health and Care Excellence (NICE) has today issued its final decision regarding the blood cancer drug Gazyvaro (obinutuzumab). 12 February 2018
Pharmaceutical
As part of a growing tradition, the new year coincides with a hike in US pharmaceutical prices, with more than 30 drugs seeing an increase in price. 12 February 2018
Pharmaceutical
At the request of Swissmedic, the Swiss Agency for Therapeutic Products, the Federal Customs Administration last year seized 1,060 shipments of illegally imported therapeutic products. 12 February 2018
Generics
Shortly after the US Government Accountability Office (GAO) issued a report accusing the FDA of failing to include product-specific guidance documents, the agency has stepped up its efforts with 57 such documents. 9 February 2018
Generics
While US President Donald Trump has talked ardently and consistently about a desire to drastically reduce prescription drug prices, the omission of the CREATES Act from the recent US budget bill suggests his intentions don’t go much further than talking. 9 February 2018
Biosimilars
YL Biologics (YLB) has announced that a Phase III clinical trial of its investigational Enbrel (etanercept) biosimilar YLB113 has met its primary endpoint. 9 February 2018
Biotechnology
In the week that it announced impressive data for apalutamide, Janssen has submitted a Marketing Authorization Application (MAA) for the new prostate cancer candidate to the European Medicines Agency (EMA). 9 February 2018
Pharmaceutical
The man in charge at Amgen has been named the new chairman of the PhRMA board of directors for the year to come. 9 February 2018
Pharmaceutical
The Bipartisan Budget Act (BBA) of 2018, currently being considered by Congress, would make changes to the Affordable Care Act’s (ACA) coverage-gap provisions for Medicare Part D that could reduce costs for patients and insurers. 9 February 2018
Biotechnology
A peer-reviewed journal of health policy thought and research has published an article claiming that the US price tag of the pioneering CAR-T therapy Kymriah (tisagenlecleucel) is overpriced by 197%. 9 February 2018
Generics
An increased dependence on the import of active pharmaceutical ingredients (APIs) from China is raising national security concerns in India, with the Health Ministry contending it is technically destroying indigenous manufacturing, reports The Pharma Letter’s India correspondent. 9 February 2018
Generics
A day after announcing that its 2018 outlook was dependent on the timing of generic competition to its blockbuster Advair/Seretide (salmeterol/fluticasone) lung drug, UK pharma major GlaxoSmithKline received a major boost relating to that very issue. 8 February 2018
Biotechnology
It was a tough start to the week for US biotech giant Gilead, with the company’s share price taking a battering in the stock market slump and after revealing financing results that revealed fading hepatitis sales. 8 February 2018
Biotechnology
The US Food and Drug Administration has approved a label update for Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis. 8 February 2018
Biosimilars
Pfizer’s manufacturing partner in South Korea Celltrion has received a warning letter from the US FDA after an inspection of its Incheon-based facility uncovered “issues related to certain manufacturing processes.” 7 February 2018
Pharmaceutical
FDA commissioner Scott Gottlieb issued a warning on Tuesday about the herbal remedy kratom, saying the latest scientific analyses provide strong evidence of the compounds’ opioid properties. 7 February 2018
Pharmaceutical
GlaxoSmithKline’s Bexsero (meningococcal group B vaccine (recombinant, adsorbed)) has become the first vaccine in the world to receive the Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) twice. 7 February 2018
Biotechnology
In contrast to much of the stock market, Zogenix was looking for further gains rather than consolidation as trading progressed into the afternoon on Tuesday. 6 February 2018
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