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-domiciled pain drugmaker Endo International says that its Qualitest subsidiary has launched a generic version of Swiss pharma major Roche Valcyte (valganciclovir) tablets USP, 450mg. 20 November 2014
The European subsidiary of Indian drugmaker Cipla has entered a distribution agreement with Serum Institute of India (SII), a global leader in the production of vaccines. 20 November 2014
The European Generic medicines Association (EGA) used the platform of European Antibiotic Awareness Day yesterday to highlight the need for good prescription practices and compliance. 19 November 2014
The Competition Commission has asked Indian generics company Sun Pharmaceutical Industries, which acquired fellow Indian drug maker Ranbaxy Laboratories in April, to amend the $3.2 billion merger, according to The Wall Street Journal. 17 November 2014
German drugmaker Stada Arzneimittel has posted financial results for the first nine months of 2014, showing that groups sales rose 4% to 1.48 billion euros ($1.84 billion), though down 1% adjusted for currency and portfolio effects. 13 November 2014
US drugmaker Mallinckrodt says it has been informed by the Food and Drug Administration that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release tablets, USP may not be therapeutically equivalent to the category reference drug, Johnson & Jonson’s Concerta. 13 November 2014
An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals into the country earlier this month may have been the last straw for the Indian government battling counterfeit drugs. 10 November 2014
Global private equity investors Advent International and Avista Capital Partners have signed an agreement to acquire Kremers Urban Pharmaceuticals, the US specialty generic pharmaceuticals subsidiary of Belgian drugmaker UCB, for $1.525 billion. 7 November 2014
Indian generics drugmaker Ranbaxy Laboratories revealed in a Bombay Stock Exchange filing that it has received communication from the US Food and Drug Administration, in which the agency said it has determined that Ranbaxy’s Abbreviated New Drug Applications of concern did not have any data integrity issues. 7 November 2014
Ireland-headquartered generics drug major Actavis today reported net revenue leapt 83% to $3.7 billion for the third quarter ended September 30, 2014. 5 November 2014
US generics drugmaker Mylan reported third-quarter 2014 financial results that beat analysts’ consensus forecasts, sending the firm’s share up 3.5% to $54.20. 31 October 2014
US generic drugmaker Mylan said yesterday that it has launched its nevirapine extended-release tablets, 400mg, which is the generic version of Boehringer Ingelheim's Viramune XR. 31 October 2014
Atlantic Canadians will save an estimated C$560 million ($500 million) through an unprecedented three-year agreement reached between Canada's provinces and territories and the generic pharmaceutical industry, Jim Keon, president of the Canadian Generic Pharmaceutical Association (CGPA), said today. 30 October 2014
Indian generics drugmaker Dr Reddy’s Laboratories today reported its unaudited consolidated financial results for the quarter ended September 30, 2014, showing that revenues grew 7% to 35.88 billion rupees ($579 million). 29 October 2014
US drugmaker The Medicines Company says that the US District Court for the Northern District of Illinois in The Medicines Company v Mylan case entered judgment in favor of TMC on all issues concerning US Patent No 7,582,727. 28 October 2014
The US District Court for the District of Delaware has upheld US pharma giant Pfizer’s basic patent and the L-malate salt patent covering Sutent (sunitinib malate) capsules. 23 October 2014
Ireland-headquartered generics major Actavis confirmed that it has prevailed in a court battle over the patent on its contraceptive pill Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets). 23 October 2014
US generic drugmaker Mylan and US drugmaker Abbott Laboratories have revised the pricing terms of their generics arrangement agreed in July. 23 October 2014
It is projected that the heparin active pharmaceutical ingredient (API) in China will achieve an additional capacity of more than 20 trillion units by 2015, when China's total capacity will exceed 30 trillion units, accounting for roughly 80% of the global demand, according to a new report. 21 October 2014
Canadian drugmaker Valeant Pharmaceuticals International has posted third-quarter 2014 financial results that beat analyst estimates, with the news pushing the shares of the company, which is embroiled in a hostile takeover of Allergan, 3.7% higher to $124.69 in mid-morning trading. 20 October 2014
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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.