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.

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).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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).

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.

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).

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.

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.