3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
With the US Generic Drug User Fee Amendments (GDUFA) reauthorized by Congress on September 30, 2022, known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027. 17 October 2022
Indian generics major Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market mirabegron extended-release tablets USP 25mg and 50mg. 3 October 2022
In a blog post, the leading trade group for the US pharmaceutical industry has slammed a recent report from the Initiative for Medicines, Access & Knowledge (I-MAK). 3 October 2022
Private equity firm SK Capital Partners has entered into a deal to acquire Apotex Pharmaceutical Holdings, a Canada-based generic drugmaker with products across all major therapeutic areas for patients around the world. 29 September 2022
Astellas Pharma saw its share gain 1.6% in early trading, though it later drifted back, as it revealed it has won a reprieve in its patent dispute with generics and biosimilar injectables specialist Hospira, albeit just short term. 26 September 2022
There was positive news from US pharma giant Merck & Co this morning, with respect to patent litigation relating to its blockbuster diabetes drug franchise. 22 September 2022
As global pharma majors exit South America after the coronavirus pandemic, India's Pharmexcil (Pharmaceuticals Export Promotion Council of India) is looking to promote Indian pharmaceutical exports in the Latin American and Caribbean Region. 14 September 2022
A breakthrough on the litigation front will extend exclusivity for certain of Gilead Sciences’ HIV meds by around six or seven years. 13 September 2022
Fast-growing contract development and manufacturing organization (CDMO), Bora Pharmaceuticals, has completed the acquisition of fellow Taiwan based TWi Pharmaceutical, a technology-based company specializing in development and commercialization of niche generic drugs. 13 September 2022
Indian drugmaker Zydus Lifesciences has been granted approval by the US Food and Drug Administration (FDA) to market lenalidomide capsules. 13 September 2022
German drugmaker STADA Arzneimittel is broadening its offering to patients, pharmacists and physicians in Europe by introducing abiraterone acetate 500mg film-coated tablets in 21 European countries. 9 September 2022
Indian drugmaker Dr Reddy’s Laboratories has launched a generic version of Bristol Myers Squibb’s cancer drug Revlimid (lenalidomide). 8 September 2022
Indian generic drugs major Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services Limited (APSL), a contract research, development and manufacturing services organization and fully owned stepdown subsidiary of Dr Reddy's, announced a Memorandum of Understanding (MoU) with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development body that develops new therapeutic solutions for neglected diseases and the DNDi India Foundation. 2 September 2022
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
STADA Arzneimittel showed persistence in a challenging operating environment marked by macroeconomic and geopolitical uncertainties to report double-digit sales and earnings growth in the first half of 2022, the German drugmaker reported today. 25 August 2022
AMPAC Fine Chemicals (AFC), an SK pharmteco company, has opened its new Complex Molecule Chemistry & Engineering Center in Rancho Cordova, California. 24 August 2022
Russia plans to rebuild its pharmaceutical sector, which has been hit significantly by international sanctions and their consequences, that will be part of the recently announced state strategy of ensuring Russia’s national drug sovereignty by reducing the country’s dependence on the imports at all stages of drug production, from intermediates to the production of pharmaceutical substances. 23 August 2022
A US federal court on Friday ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 22 August 2022
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.