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
China’s State Council, the executive body that oversees government operations, has listed a series of improvements that are needed for the selection and adoption of essential drugs. 21 September 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its September 2018 meeting recommended 13 medicines for approval, including three orphan medicines that are covered in a separate article. 21 September 2018
Biotechnology
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its September 2018 meeting recommended 13 medicines for approval, including three orphan medicines, with the latter being the following. 21 September 2018
Generics
A review of pending legislation from the non-partisan Congressional Budget Office (CBO) says the bill would allow generics to hit the shelves more quickly and enable the US Government to spend less on prescription drugs. 21 September 2018
Pharmaceutical
Privately-held French drugmaker Pierre Fabre has announced that the European Commission (EC) has approved the combination of Braftovi (encorafenib) and Mektovi (binimetinib) for unresectable or metastatic melanoma with a BRAF mutation, as detected by a validated test. 21 September 2018
Pharmaceutical
In what was clearly an active session for the Japanese Ministry of Health, Labor and Welfare (MHLW), four new drug approvals were announced this morning. 21 September 2018
Biotechnology
A few short months after Merck & Co won its first Chinese approval for flagship immuno-oncology product Keytruda (pembrolizumab), the firm has reportedly agreed a price reduction plan that will enable patients to gain access for around half the US list price. 20 September 2018
Biotechnology
Following US approval last month, soon-to-be Takeda Pharmaceutical acquisition Shire has now also been granted authorization in Canada for Takhzyro (lanadelumab), as a treatment for hereditary angioedema (HAE). 20 September 2018
Biosimilars
The prospect of reducing treatment costs for payors supports a positive future for biosimilars, according to new research released today. 20 September 2018
Pharmaceutical
The US Department of Health and Human Services (HHS) is spending big in a sign of how seriously it is taking the opioid epidemic. 20 September 2018
Pharmaceutical
A new white paper authored by Bruce Pyenson and colleagues from Milliman explains why the US Institute for Clinical and Economic Review (ICER) cost-effective analyses (CEAs) will not be very useful for private payers’ medicine coverage decisions. 20 September 2018
Biotechnology
Although Novartis’ CAR-T therapy Kymriah (tisagenlecleucel-T) was accepted onto the UK’s Cancer Drugs Fund (CDF) for children with a type of leukemia, adults with diffuse large B-cell lymphoma (DLBCL) have not yet been afforded the same treatment. 19 September 2018
Pharmaceutical
Latvia’s leading pharmaceutical trade group has issued a statement welcoming healthcare reforms in the country and strongly supporting their continuation. 19 September 2018
Pharmaceutical
The status of tuberculosis (TB) as the world’s leading killer among infectious diseases has been underlined by the Global Fund amid a report’s claim of a funding gap of $3.5 billion in 2018 alone in the fight to end its deadly impact. 19 September 2018
Pharmaceutical
Lawmakers in the US House of Representatives have ditched a widely-supported amendment that would have changed the rules on advertising pharmaceutical products, requiring drugmakers to list prices in TV adverts. 19 September 2018
Pharmaceutical
The roll-out of Ilumetri (tildrakizumab) is to take place over the next few weeks following European Commission approval of the humanized high-affinity anti-IL-23p19 monoclonal antibody. 19 September 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has underlined that it is serious about ensuring appropriate and rational prescribing of opioids to counteract their misuse, as the agency approved new safety measures governing their use. 19 September 2018
Pharmaceutical
Following a public comment period, the US Federal Trade Commission has approved a final order that settles charges that Catalan pharma-chemical company Grifols’ $286 million acquisition of USA-based Biotest Pharmaceuticals is anticompetitive and violates federal antitrust law. 19 September 2018
Biotechnology
Netherlands-based Pharming Group saw its share plunge 29.05% to 0.69 euros by mid-morning today, after it revealed a further setback in its attempt to widen the use of its leading drug. 19 September 2018
Generics
A proposal to fix a side effect of Europe’s Supplementary Protection Certificate (SPC) has taken a step closer to introduction. 18 September 2018
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