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
Ireland-incorporated drugmaker Endo International has continued its drive to realize efficiency savings with a new round of layoffs, focusing on its US-based corporate and R&D functions. 26 January 2017
The healthcare sector in India catering to the unmet health needs of the society should be kept out of the purview of the Goods and Services Tax (GST) or else medical care would become expensive and unaffordable for the ordinary people. 25 January 2017
Beximco Pharmaceuticals has entered into a collaboration with Malaysia’s BioCare Manufacturing, in what will be the Bangladeshi generics firm’s first overseas manufacturing deal. 25 January 2017
Endo International has resolved its antitrust dispute with the US Federal Trade Commission (FTC), via a joint motion filed in a Californian district court. 24 January 2017
UK-headquartered Mallinckrodt has reached a $100 million settlement over a Federal Trade Commission complaint that it violated antitrust laws. 19 January 2017
A drug that's commonly used to treat high blood pressure is being repurposed for a rare tissue cancer in Europe. The medication, named propranolol, was recently granted Orphan Drug Designation by the European Commission (EC). 18 January 2017
Zydus Pharmaceuticals, a US subsidiary of Indian drugmaker Cadila Healthcare, has reached an out of court agreement with Kowa Pharmaceuticals and Nissan Chemical Industries, bringing to an end their ongoing patent infringement dispute. 17 January 2017
The US Food and Drug Administration has published draft guidance relating to the 180-day exclusivity for generic drug product provisions as the agency seeks to establish its current approach to this topic. 16 January 2017
There were two new developments in the backlash against Mylan’s US pricing policy for its EpiPen Auto-Injector (epinephrine injection, USP) this week. 13 January 2017
Indian drugmaker Cadila Healthcare and its US subsidiary today announced that they have finalized an agreement with privately-held US generics firm Upsher-Smith Laboratories, to settle all outstanding patent litigation related to Qudexy XR (topiramate) extended-release capsules. 13 January 2017
Nothing could be further from the truth than an assumption held by many Westerners that nothing changes in Japan, writes long time pharma industry watcher P Reed Maurer, who is president of International Alliances Limited. 12 January 2017
Chronic therapies, especially anti-diabetic and cardiac care are helping the Indian pharmaceutical market notch up healthy growth figures, reports The Pharma Letter’s India correspondent. 11 January 2017
US generic drugmaker Impax Laboratories today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration containing a paragraph IV certification for a generic version of Aubagio. 6 January 2017
Israeli generics giant Teva Pharmaceutical Industries felt the force of a Friday battering in the stock market after reducing its revenue forecast for 2017 by more than $1 billion. 6 January 2017
Wockhardt on Wednesday revealed that it had received another US Food and Drug Administration warning letter for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat. 5 January 2017
Russian drugmakers will be allowed to produce one drug under different brand names, which should help to accelerate the process of import substitution in the industry, according to a recent decision of the Russian government. 3 January 2017
A new study shows that the drug fenofibrate might reduce the risk of cardiovascular events in patients with type 2 diabetes who have high levels of triglycerides and low levels of "good" cholesterol, despite being treated with statins. 29 December 2016
Indian pharma company Zydus Cadila has acquired a range of drug brands which fall in the men’s health, women’s health, wound management and cardiovascular therapy segments for marketing in India. 28 December 2016
Pfizer and Russia’s NovaMedica have completed the last stage of negotiations for a long-term strategic partnership designed to transfer the rights and technologies for the production of more than 30 life-saving and essential drugs from the Pfizer product portfolio. 27 December 2016
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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.