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Inflexion Outlines Rosemont Investment And Eyes More Generics Deals

In an exclusive interview with Generics Bulletin, Inflexion’s Ben Long reveals his ambitions for newly-acquired UK-based liquids generics specialist Rosemont Pharmaceuticals, including to drive investment in R&D and expand the company’s international footprint.

Generic Drugs Strategy

Coronavirus Spotlight


Coronavirus Spotlight

Generics Industry Counts Cost Of Stormy Second Quarter

As the global generics industry had predicted, the unexpected growth seen in the first quarter of 2020 due to forward buying caused by COVID-19 levelled off in the second quarter. However, a few companies managed to report a “mixed” second quarter or a positive first half for 2020, even after experiencing challenges, such as operational interruptions, posed by the pandemic.

Coronavirus COVID-19 Generic Drugs

The Global Generics & Biosimilars Awards 2020 Is Going Digital

The Global Generics & Biosimilars Awards 2020 will take place on 3 November as a digital event, with a newly-extended entry deadline date of 14 August.

Generic Drugs Biosimilars Value-Added Medicines

Hikma Is Keeping On Top Of COVID ‘Rollercoaster’

Careful supply-chain planning and an agile, flexible approach to manufacturing have been key in helping Hikma to stay on top of the “rollercoaster ride” provided by the COVID-19 pandemic in 2020 so far, according to CEO Siggi Olafsson.

Strategy Coronavirus COVID-19 Generic Drugs
 

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Inflexion Outlines Rosemont Investment And Eyes More Generics Deals

In an exclusive interview with Generics Bulletin, Inflexion’s Ben Long reveals his ambitions for newly-acquired UK-based liquids generics specialist Rosemont Pharmaceuticals, including to drive investment in R&D and expand the company’s international footprint.

Generic Drugs Strategy

Teva Completes ‘Digihaler Family’

Teva has completed its portfolio of digital inhalers by launching a further two products, AirDuo Digihaler (fluticasone propionate/salmeterol) and ArmonAir Digihaler (fluticasone propionate), in the US. The pair join the firm’s previously launched ProAir Digihaler (albuterol sulfate).

Digital Health Value-Added Medicines

Can RFID Tags Give Generics Companies An Edge?

Fresenius Kabi’s decision to add radio frequency-identification (RFID) tags to 24 products used in hospital operating rooms will help the company’s hospital pharmacy customers reduce waste, increase efficiencies and facilitate tighter medication inventory control, executives claim. However, only 10% of US hospitals are currently equipped to scan and process RFID tags, despite larger adoption rates in other industry sectors. COVID-19-related revenue losses may push more hospitals to adopt automated RFID medication management systems to save time and reduce labor costs.

Strategy Generic Drugs

Bankruptcy Court Gives Green Light To Akorn Sale

Just three years after Fresenius Kabi agreed a $4.75bn takeover of the US injectables specialist, Akorn has obtained approval from a US bankruptcy court for its sale to the company’s existing lenders, having filed for Chapter 11 bankruptcy earlier this year.

Deals Strategy

Neuraxpharm Snapped Up By Private Equity In Europe’s Largest Deal

Created in 2016 by consolidating five European companies, CNS specialist Neuraxpharm is changing hands, with funds advised by global investor Permira paying an undisclosed sum to take control of a business boasting annual revenues of around €460m ($541m) and more than 115 CNS molecules at its disposal.

Deals M & A

Alvogen’s Lotus Picks Up Darbepoetin Alfa Rights In Asia

Lotus Pharmaceuticals has expanded its biosimilar pipeline to five by bringing in rights in Taiwan and South East Asia markets to Chong Kun Dang Pharmaceutical’s biosimilar of Kyowa Kirin’s Nesp (darbepoetin alfa).

Deals Biosimilars
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Policy & Regulation Explore this Topic

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Hikma’s Latest Advair Setback Pushes It Closer To Rivals

Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.

Generic Drugs Regulation

AAM Ramps Up US Election Lobbying

The AAM has published a timely guide highlighting various voter issues of concern in the run-up to the US elections, including anti-competitive tactics building on monopoly pricing and weak patent laws. The AAM has also called for policies to encourage generic and biosimilar entry in the market while the guide also focuses on policies around the US supply chain.

Policy Elections

Accord Gets First EU-Wide Nod For Xarelto Rival

Accord Healthcare has garnered the first positive opinion recommending granting a pan-European marketing authorization for a generic version of rivaroxaban from the EMA’s CHMP. However, originator Bayer claims that no generic competition will be possible for another three years.

Generic Drugs Regulation

EMA Endorses Dexamethasone For COVID-19

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

Generic Drugs Regulation

Pfizer Lines Up European Pegfilgrastim

Pfizer has received an endorsement for a pan-European marketing authorization for its Nyvepria pegfilgrastim biosimilar from the EMA’s CHMP. However, the company would not be drawn on commercialization plans amid competition from numerous other approved versions.

Biosimilars Regulation

US Bill Urges Automatic Insulin Interchangeability

A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.

United States BioPharmaceutical
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Inflexion Outlines Rosemont Investment And Eyes More Generics Deals

In an exclusive interview with Generics Bulletin, Inflexion’s Ben Long reveals his ambitions for newly-acquired UK-based liquids generics specialist Rosemont Pharmaceuticals, including to drive investment in R&D and expand the company’s international footprint.

Generic Drugs Strategy

Mylan Symbicort Trial Looms As Company Eyes First US Generic

A trial will begin next month in Mylan’s bid to overcome patents shielding AstraZeneca’s Symbicort respiratory brand in the US. With rival Teva having previously settled ANDA action, Mylan is in the driving seat for a first substitutable generic.

Intellectual Property Legal Issues

Can RFID Tags Give Generics Companies An Edge?

Fresenius Kabi’s decision to add radio frequency-identification (RFID) tags to 24 products used in hospital operating rooms will help the company’s hospital pharmacy customers reduce waste, increase efficiencies and facilitate tighter medication inventory control, executives claim. However, only 10% of US hospitals are currently equipped to scan and process RFID tags, despite larger adoption rates in other industry sectors. COVID-19-related revenue losses may push more hospitals to adopt automated RFID medication management systems to save time and reduce labor costs.

Strategy Generic Drugs
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Biosimilars Explore this Topic

Set Alert for Biosimilars

AAM Ramps Up US Election Lobbying

The AAM has published a timely guide highlighting various voter issues of concern in the run-up to the US elections, including anti-competitive tactics building on monopoly pricing and weak patent laws. The AAM has also called for policies to encourage generic and biosimilar entry in the market while the guide also focuses on policies around the US supply chain.

Policy Elections

Alvogen’s Lotus Picks Up Darbepoetin Alfa Rights In Asia

Lotus Pharmaceuticals has expanded its biosimilar pipeline to five by bringing in rights in Taiwan and South East Asia markets to Chong Kun Dang Pharmaceutical’s biosimilar of Kyowa Kirin’s Nesp (darbepoetin alfa).

Deals Biosimilars

Pfizer Lines Up European Pegfilgrastim

Pfizer has received an endorsement for a pan-European marketing authorization for its Nyvepria pegfilgrastim biosimilar from the EMA’s CHMP. However, the company would not be drawn on commercialization plans amid competition from numerous other approved versions.

Biosimilars Regulation
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Value-Added Medicines Explore this Topic

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Teva Completes ‘Digihaler Family’

Teva has completed its portfolio of digital inhalers by launching a further two products, AirDuo Digihaler (fluticasone propionate/salmeterol) and ArmonAir Digihaler (fluticasone propionate), in the US. The pair join the firm’s previously launched ProAir Digihaler (albuterol sulfate).

Digital Health Value-Added Medicines

Neuraxpharm Buccolam Acquisition Opens Up Opportunities

Neuraxpharm says a deal with Takeda to acquire the only buccal midazolam approved across Europe, Buccolam, not only gives the CNS specialist a strong asset but also offers the opportunity to expand its commercial footprint into the Nordics and Ireland.

Deals Value-Added Medicines

Actavis Waits On Alimta Hybrid Following FDA Approval

FDA approval for a hybrid 505(b)(2) new drug application referencing Alimta has been awarded to Teva’s Actavis, with a key patent expiring in May 2022 proving a barrier to market entry. Teva was itself shot down over attempts to launch an ANDA product several years ago.

Approvals Value-Added Medicines
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