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.
Mark Engelman, head of intellectual property at UK-based law firm Hardwicke, offers his interpretation on a landmark ruling in an Expert View piece. 5 September 2017
The US Food and Drug Administration on Friday granted tentative approval for Admelog (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analogue. 4 September 2017
Bain Capital and Cinven announce their intention to nominate Claudio Albrecht as new chief executive and Mark Keatley as new chief financial officer of Stada Arzneimittel, the German generic drugmaker they are in the process of acquiring. 4 September 2017
The late Canadian novelist Robertson Davies once remarked that the eye sees only what the mind is prepared to comprehend. He could almost have been referring to oft-reported negative experiences of patients switching from branded to generic drugs. 1 September 2017
Following a public comment period, the Federal Trade Commission (FTC) has approved a final order designed to remedy the anticompetitive effects resulting from Baxter International’s proposed $625 million acquisition of India-based Claris Lifesciences’ injectable drugs business. 31 August 2017
Par Pharmaceuticals has begun shipping vigabatrin for oral solution USP, 500mg per packet following final approval from the US Food and Drug Administration for its Abbreviated New Drug Application. 29 August 2017
Stada Pharmaceuticals Australia and BioQ Pharma have signed a strategic agreement to commercialize three ready-to-use infusion pharmaceuticals in Australia and New Zealand. 29 August 2017
Germany has a historical reputation as being a global leader in the pharmaceutical industry, being the headquarters of many global stalwarts such as Bayer, BASF, Stada, etc, according to a report added to Research and Markets offering, titled: "Analyzing Generics Market in Germany 2017." 25 August 2017
Danish specialty pharma firm Xellia Pharmaceuticals has completed the expansion of its new $13 million, Centralized Laboratory Services building at its Budapest, Hungary, manufacturing site. 22 August 2017
Russian drugmakers and foreign companies operating in the country have significantly increased the volume of pharmaceutical substances imports this year, a spokesman for Veronika Skvortsova, Russia’s Minister of Health, recently said, reports The Pharma Letter’s local correspondent. 21 August 2017
India’s Department of Pharmaceuticals’ (DoP) draft Pharmaceuticals Policy has been set out to further the key aims of Prime Minister Narendra Modi of making it easier to do business in the drug development industry, and to boost the Make in India program. 21 August 2017
Shares of German generics drugmaker Stada Arzneimittel leapt 13.18% to 72.55 euros on Friday, after it became clear that the proposed 4.1 billion-euro ($4.8 billion) takeover of the company would finally proceed. 21 August 2017
Netherlands-based Mylan has reached an agreement with the US Department of Justice finalizing the previously announced Medicaid drug rebate settlement of $465 million. 17 August 2017
Shares of Jordan-based Hikma Pharmaceuticals (LSE: HIK) dropped 11.8% to £11.75 in early London trading today, after it reported its interim results for the six months ended June 30, 2017 and expansion of a marketing deal with Japan’s largest drugmaker. 17 August 2017
Canada’s Valeant Pharmaceuticals International says the US Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida, as part of a forthcoming Establishment Inspection Record for the facility. 17 August 2017
At two years after the entry of the first copycat product, the penetration of generic drugs reaches 21.4% of the market in Mexico, where in the USA it climbs to 89% and in Canada it is 74%. 16 August 2017
Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings, the US Food and Drug Administration announced today. 16 August 2017
Zydus Pharmaceuticals, an American generics company and subsidiary of Cadila Healthcare, has settled litigation with privately-held Aptalis Pharma related to the ulcerative colitis treatment Canasa. 14 August 2017
Pharma breathed a sigh of relief when, after months of strident rhetoric damning the industry, President Trump picked industry insider Scott Gottlieb as the new FDA Commissioner. 11 August 2017
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
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Company Spotlight
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.