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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Generics
Following a record year for generic drug approvals in 2017, the US Food and Drug Administration yesterday issued the draft guidance for industry “Good ANDA Submission Practices,” which highlights common, recurring deficiencies in Abbreviated New Drug Applications (ANDAs) that may lead to a delay in the approval of an ANDA. 4 January 2018
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to Kisqali (ribociclib) for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor. 3 January 2018
Biotechnology
The UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending gene therapy Strimvelis, from UK pharma major GlaxoSmithKline, as an option for treating an extremely rare immune deficiency condition, confirming an October preliminary opinion. 3 January 2018
Pharmaceutical
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for Azedra (iobenguane I 131) in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. 2 January 2018
Biotechnology
Funding cetuximab for patients with head and neck cancer will be a significant advance for treating this type of cancer in New Zealand, says Sarah Fitt, director of operations at the Pharmaceutical Management Agency PHARMAC. 2 January 2018
Pharmaceutical
The overall performance of Indian pharmaceutical companies on stock markets remained significantly under pressure during the full year 2017 on account of single digit growth in top line as well as bottom line, US Food and Drug Administration actions against major Indian pharma companies in respect of quality, demonetization, GST [tax] implementation and price cuts. 2 January 2018
Pharmaceutical
2017 ended with a couple of significant acquisitions stories: Roche’s $1.7 billion deal to buy Ignyta and Mallinckrodt’s $1.2 billion purchase of Sucampo Pharmaceuticals. There was also a flurry of year-end activity from the US Food and Drug Administration, which granted early approval for Aerie Pharmaceuticals’ glaucoma drug Rhopressa, as well as approvals for Exelixis’ cabozantinib and for Merck & Co and Pfizer’s Steglatro. Also attracting attention was Orchard Therapeutics’ fund raising. 31 December 2017
Biosimilars
The first biosimilar version of Roche’s blockbuster Herceptin (trastuzumab) has been approved in Brazil by ANVISA, the country’s medicines regulatory agency. 29 December 2017
Pharmaceutical
Health Canada is advising Canadians and healthcare professionals that new safety warnings will be added to the product safety information of the following sedative and anesthetic drugs when they are used in early childhood and during pregnancy. 29 December 2017
Pharmaceutical
The US Food and Drug Administration has accepted for filing with Priority Review the recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy. 28 December 2017
Biotechnology
Pfizer today announced that its appeal has been upheld against the National Institute for Health and Care Excellence’s (NICE) decision not to recommend Besponsa (inotuzumab ozogamicin) as a treatment for adults with relapsed or refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). 28 December 2017
Biotechnology
The US Food and Drug Administration has lifted the clinical hold, previously announced on October 7, 2017, on Phase I/II clinical trial of SEL24 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). 28 December 2017
Biotechnology
The US Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Report-at-a-Glance on vesicular monoamine transporter 2 (VMAT2) inhibitors for management of tardive dyskinesia (TD), saying that the evidence suggests these drugs offer short-term benefits but are ‘vastly overpriced’. 27 December 2017
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). 27 December 2017
Generics
The Russian national Parliament (State Duma) plans to approve a bill that will ease imports of active pharmaceutical ingredients (APIs) to the country, according to press-service of the Russian Duma, reports The Pharma Letter’s local correspondent. 26 December 2017
Pharmaceutical
The US Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets. 26 December 2017
Biotechnology
The European Commission has granted a marketing authorization for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). 23 December 2017
Biotechnology
The US Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. 22 December 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC). 22 December 2017
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter (CRL) for the New Drug Application (NDA) for intravitreal (IVT) sirolimus (DE-109). 22 December 2017
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
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