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Generics
The US affiliate of Teva Pharmaceutical Industries announced today the launch of an authorized generic of Victoza (liraglutide injection 1.8mg), in the USA. 24 June 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Generics
Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe. 21 March 2024
Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Generics
Indian drugmaker Sun Pharmaceutical has increased its bid to acquire Israeli generics firm Taro Pharma, up to $43 per share from its previous offer of $38 per share. 14 December 2023
Generics
Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, the US Food and Drug Administration (FDA) has determined the risk evaluation and mitigation strategy (REMS) for the drugs are no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation. 9 September 2023
Generics
Privately-held UK headquartered Advanz Pharma has signed an exclusive licensing and supply agreement with GP Pharm for a peptide specialty injectable generic in a rare disease indication for multiple European countries. 4 September 2023
Generics
A California federal jury cleared Gilead Sciences and Teva Pharmaceutical Industries on Friday in a $3.6 billion antitrust case claiming the pharmaceutical giants struck an illegal "pay for delay" patent deal that inflated prices for two HIV medications. 1 July 2023
Generics
Indian drugmaker Lupin Limited has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for tiotropium bromide inhalation powder, 18 mcg/capsule, a generic equivalent of German pharma major Boehringer Ingelheim’s Spiriva HandiHale. 22 June 2023
Generics
Today, the US Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 13 June 2023
Generics
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. 19 May 2023
Generics
Japanese drug major Astellas Pharma today confirmed that the US Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement of Lexiscan (regadenoson injection) 0.4mg/mL. 11 May 2023
Generics
RedHill Biopharma has published new data for its antibiotic Talicia (omeprazole/amoxicillin/rifabutin), focused on differentiating the brand from generic alternatives. 10 May 2023
Generics
Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals. 9 February 2023
Generics
Japanese drugmaker Chugai Pharmaceuticals, which is majority-owned by Roche, says that the Intellectual Property High Court has rendered judgment to dismiss the plaintiff’s appeal filed on June 9, 2022, regarding generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) Capsule 0.5µg/0.75µg. 14 December 2022
Generics
The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, titled “Statistical Approaches to Establishing Bioequivalence,” which provides recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. 3 December 2022
Generics
New Jersey, USA-based Amneal Pharmaceuticals today said it has launched commercial operations in India. 10 October 2022
Generics
The US Food and Drug Administration has published more information related to recent changes to Generic Drug User Fee Amendments (GDUFA). 7 October 2022
Generics
UK provider of niche generic and branded specialty pharmaceuticals Aspire Pharma says it has completed its acquisition of privately-held Morningside Pharmaceuticals (Loughborough), Morningside Healthcare (Leicester) and Morningside Healthcare (India). 3 October 2022
Generics
The Court of Appeals for the Federal Circuit ruled in favor of Merck & Co in a patent challenge brought by Mylan Pharmaceuticals (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR (sitagliptin and metformin hydrochloride extended-release). 30 September 2022
Generics
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas Pharma. 24 January 2023
Generics
As a blockbuster heart failure drug by Swiss pharma giant Novartis goes off-patent, several Indian drug majors are rushing to market with their generic applications. The patent loss of Entresto (sacubitril/valsartan) has brought on significant disruptions in India’s cardiology sector. High courtroom drama ensued a few days before the patent loss and had everyone on tenterhooks, reports The Pharma Letter’s India correspondent. 20 January 2023
Generics
India's interim free trade agreement with Australia is set to offer a significant relaxation of factory inspections, which could pave the way for many more commercial deals with developed countries, according to Pharmexcil, India's pharmaceutical export promotion council. 16 January 2023
Generics
A sudden surge in Covid cases in China has made anti-Covid generic drugs from India attractive, including the generic version of Pfizer's anti-Covid oral drug Paxlovid (nirmatrelvir/ritonavir), which is in high demand and needs to be reserved weeks in advance, reports The Pharma Letter's local correspondent, 12 January 2023
Generics
Drug imports to Russia are ongoing almost in the same volumes as in the past, despite the current situation in Russia, according to recent statements by Viktor Dmitriev, general director of the Association of Russian Pharmaceutical Manufacturers (ARPM) and some independent local analysts in the field of pharmaceuticals. 10 January 2023
Generics
PSK Pharma, a Russian drugmaker that is part of the local Rus Biopharm Group, is looking to become one of the leading pharmaceutical companies in Russia in the coming years to come, achieving this by a significant increase of its output and expansion of its range, reports The Pharma Letter’s local correspondent. 10 January 2023
Generics
Finnish drugmaker Orion Corporation says it has signed a long-term license agreement with US drugmaker Amneal Pharmaceuticals, to commercialize Amneal’s generic products in Orion territories. 5 January 2023
Generics
In November 2022, the US Food and Drug Administration (FDA) hosted a webinar on the topic Understanding Generic Narrow Therapeutic Index (NTI) Drugs. The aim of the webinar was to educate healthcare professionals on NTI drugs and the FDA’s efforts to ensure therapeutic equivalence of generic NTI drugs.1 3 January 2023
Generics
The supervisory board of German drugmaker STADA Arzneimittel has appointed Boris Döbler as group chief financial officer (CFO) with effect from January 1, 2023. 3 January 2023
Generics
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Generics
Global drugmakers have significantly cut their portfolios in the Russian market in recent years due to the decline of profitability and low prices under public procurement programs. 28 December 2022
Generics
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
Generics
In what could well be India's biggest pharma deal, China's Fosun Pharma-owned Gland Pharma is on the block. A number of private equity firms have been approached, including Baring Private Equity, Bain Capital, Blackstone, Carlyle, and KKR. 19 December 2022
Generics
The Russian government together with some leading domestic financial corporations will provide support to domestic producers of active pharmaceutical ingredients (APIs) that will primarily be in the form of provision of preferential loans and other benefits for them, reports The Pharma Letter’s local correspondent. 15 December 2022
Generics
Swiss contract development and manufacturing organization (CDMO) Lonza today announced the start of new mid-scale manufacturing assets at its active pharmaceutical ingredients (API) manufacturing center in Nansha, China. 5 December 2022
Generics
The Russian drugmaker PSK Pharma has launched the production of tofacitinib – a generic version of Pfizer’s Xeljanz/Jaquinus drug, reports The Pharma Letter’s local correspondent. 28 November 2022
Generics
Several Indian pharmaceutical companies are facing the dual challenges of antitrust investigations and being sued by multinational pharmaceutical companies. There has been an increase in probes by the US regulator for possible market failures, such as failure to follow good manufacturing practices and deviations from the regulatory path, in the past few months, with multiple cases scorching the growth plans of Indian drug companies, reports The Pharma Letter’s India correspondent. 28 November 2022
Generics
STADA Arzneimittel has replaced the departing Carsten Cron with Stéphane Jacqmin as head of emerging markets at the German firm. 23 November 2022
Generics
Leading Indian and Chinese drugmakers are considering accelerating their expansion into the Russian market – in a move to fill vacant niches that appeared after the reduction of presence of Western pharmaceutical companies in recent months following the invasion of Ukraine. 23 November 2022
Generics
A couple of months ago, Teva Pharmaceutical Industries’ chief executive Kåre Schultz indicated that he will not renew his contract as chief executive come November 2023, as the Israeli generics giant revealed plans to finalize its $4.35 billion national opioid settlement by the end of the year and start paying up in 2023, as well as reporting a loss in three out of the last four quarters. 21 November 2022
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