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Featured Stories


 

German Medicines Safety Law Will ‘Do Nothing Against Shortages’

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.

Germany Legislation

Oxytetracycline Prices Double As Hydrocortisone Plunges In UK

July saw UK generic trade price rises peak at a 100% increase for oxytetracycline 250mg tablets, while hydrocortisone 20mg tablets saw their average price plummet by two-thirds, according to the latest figures from WaveData.

United Kingdom Pricing Strategies Market Intelligence

Aspen Will Pay UK's NHS £8m In Landmark Deal Following Competition Probe

Aspen has agreed to pay the National Health Service £8m following an investigation by the Competition and Markets Authority.

Compliance Legal Issues United Kingdom
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Embedding Time-Critical Scheduling in Drug Production

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Commercial Explore this Topic

Teligent Prepares For Injectables Filings With Strengthened Team

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. 

United States Business Strategies

Advanz Has Six Deals In The Works As It Cuts Its Losses

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

M & A Deals

Bortezomib Boom Benefits Stada But Pemetrexed Position Proves Perplexing

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.

Sales & Earnings Intellectual Property

Sagent Slides To A Loss, Dragging Down Nichi-Iko’s Margin

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.

Sales & Earnings Japan

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

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.

Value-Added Medicines Deals

Lupin Q1 Profit Up 50% But Regulatory Overhang, Slow Product Scale-Up Sparks Concern

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.

Manufacturing Business Strategies
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Policy & Regulation Explore this Topic

German Medicines Safety Law Will ‘Do Nothing Against Shortages’

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.

Germany Legislation

Dr Reddy's Is Knocked Back On US NuvaRing And Copaxone Rivals

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.

Regulation United States

Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

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.

Value-Added Medicines FDA

End Of Road For ‘Too Complex’ EU Pilot Program On Splitting Marketing Licenses

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.

Europe Generic Drugs

Pooled Data Among AAM’s Concerns On FDA’s Therapeutic Protein Biosimilars Guidance

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 Regulation

International Regulators Dismiss Scares On Biosimilar Safety

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.

Biosimilars Safety
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Generic Drugs Explore this Topic

Latest From Generic Drugs

Industry Pact Aligns Canadian Prices To International Levels

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.

Canada Pricing Debate

Teligent Prepares For Injectables Filings With Strengthened Team

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. 

United States Business Strategies

Sanders Maintains The Pressure On Teva, Mylan and Heritage

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.

Pricing Debate Pricing Strategies
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Biosimilars Explore this Topic

Latest From Biosimilars

German Medicines Safety Law Will ‘Do Nothing Against Shortages’

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.

Germany Legislation

Lupin Q1 Profit Up 50% But Regulatory Overhang, Slow Product Scale-Up Sparks Concern

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.

Manufacturing Business Strategies

US Appeals Court Denies Genentech Injunction Over Amgen's 'At Risk' Trastuzumab Launch

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

Biosimilars Intellectual Property
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Value-Added Medicines Explore this Topic

Latest From Value-Added Medicines

Advanz Has Six Deals In The Works As It Cuts Its Losses

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

M & A Deals

Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

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.

Value-Added Medicines FDA

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

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.

Value-Added Medicines Deals
See All
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