As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

Advanz Pharma’s business development team is busty assessing potential deals as the recapitalized company works towards restoring profitability on an eroding revenues base.

Launching the oncology drug bortezomib in 14 European countries helped Stada to record an 11% increase in both Generics and group sales in the first half of 2019. But the German group, which is about to start rolling out biosimilar teriparatide, has suffered a legal setback on pemetrexed in its home market.

An operating loss recorded by its US Sagent affiliate depressed Nichi-Iko’s group operating margin to just 3.7%, even though the Japanese generics specialist’s turnover increased by a tenth on strong domestic generics demand.

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.

Lupin’s first-quarter net profit soared nearly 50%, but the strong performance was overshadowed by concerns about regulatory overhang and slower-than-expected scale-up of new products that could jeopardize future revenue growth momentum.

A provision in new German legislation that requires insurance funds to consider a variety of suppliers will do nothing to address drug shortages because it is not obligatory, local industry association Pro Generika believes.

Dr Reddy’s has received a further CRL from the US Food and Drug Administration over its application for a generic rival to Merck Sharp & Dohme’s NuvaRing contraceptive, along with a CRL for its version of Teva’s Copaxone.

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.

Three key areas for improvement in in the FDA’s draft guidance on therapeutic protein biosimilars have been highlighted by industry association AAM. Pharmaceutical giants such as Pfizer, Novartis and Celltrion have also expressed concerns highlight shortcomings and sought clarification.

Biosimilars have been shown to be safe and effective, and healthcare professionals should discount any scaremongering by big pharma to the contrary, the world’s leading regulatory agencies have stated.

An agreement between industry and authorities in effect from April last year is already having a major effect in ensuring Canadian generics prices are similar to those in other developed markets, an official report shows.

As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

After urging the US DoJ to act against pharma companies alleged to have conspired in a price-fixing conspiracy, Bernie Sanders and Elijah Cummings write letters to Teva, Mylan and Heritage, accusing the companies of obstructing their enquiry.

A provision in new German legislation that requires insurance funds to consider a variety of suppliers will do nothing to address drug shortages because it is not obligatory, local industry association Pro Generika believes.

Lupin’s first-quarter net profit soared nearly 50%, but the strong performance was overshadowed by concerns about regulatory overhang and slower-than-expected scale-up of new products that could jeopardize future revenue growth momentum.

Genentech has been denied its request for a US injunction against Amgen over its at-risk launch of a trastuzumab biosimilar rival to Herceptin.

Advanz Pharma’s business development team is busty assessing potential deals as the recapitalized company works towards restoring profitability on an eroding revenues base.

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.