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Featured Stories


 

Coronavirus Puts The Brakes On Mylan-Upjohn Merger

Mylan and Pfizer’s Upjohn were all set to merge into Viatris by midway through this year, subject to certain approvals, but that will now not happen in that timeframe as the global coronavirus pandemic proves an insurmountable barrier to getting the deal over the line.

Deals Coronavirus COVID-19

Coronavirus Spotlight


Coronavirus Spotlight

India’s IPA Sees No Imminent Coronavirus Shortages

The Indian Pharmaceutical Alliance is working closely with the World Health Organization and International Generic and Biosimilar Medicines Association, as well as regional off-patent industry bodies in the US and Europe, to “navigate challenges on the manufacturing and logistics front” due to the coronavirus pandemic. Meanwhile, the IPA has welcomed domestic initiatives to boost API manufacturing.

India Coronavirus COVID-19

IQVIA Backs Global Generics & Biosimilars Awards 2020

IQVIA has joined the Global Generics & Biosimilars Awards 2020 as headline sponsor, while West AccelTRA will lend its backing to the awards as a category sponsor. The awards, which are free to enter and attend, will take place in October 2020 in Milan, Italy.

Generic Drugs Biosimilars Value-Added Medicines

Hikma Awaits Advair Opportunity

Hikma still sees a substantial opportunity in the generic Advair Diskus market once it makes it to market, according to CEO Siggi Olafsson, while rivals to GSK’s Ellipta range will also be coming into focus several years down the line. Meanwhile, nasal sprays gained through deals with Insys and Glenmark will aid in efforts to differentiate the firm’s non-injectables business in the US.

Strategy Generic Drugs United States
 

Commercial Explore this Topic

Coronavirus Puts The Brakes On Mylan-Upjohn Merger

Mylan and Pfizer’s Upjohn were all set to merge into Viatris by midway through this year, subject to certain approvals, but that will now not happen in that timeframe as the global coronavirus pandemic proves an insurmountable barrier to getting the deal over the line.

Deals Coronavirus COVID-19

Mylan Gives Up Exclusivity For US Kaletra Rival

Mylan has waived US exclusivity rights to its generic version of AbbVie’s Kaletra, which is being investigated as a treatment for COVID-19, after a week of activity that has seen Israel move to compulsory-license generic versions of the brand and the originator step back from enforcing related intellectual property worldwide.

Generic Drugs Intellectual Property

Who’s Hired? Former Actavis Chief Bisaro Lands A New Role

Industry veteran Paul Bisaro has joined the board of TherapeuticsMD and Mylan has announced new Viatris appointments, while Amneal brings in a new CFO at the same time as Fresenius Kabi’s biosimilars head exits the company.

Appointments Strategy

48 US States Support Mallinckrodt Opioid Settlement

Despite the delay in a New York state opioid trial due to coronavirus, a motion has been filed to remove Mallinckrodt and SpecGx from proceedings. However, Nassau County opposed the motion.

Legal Issues United States

Alvotech And DKSH Partner On Adalimumab In Asia

Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.

Deals Biosimilars

India’s IPA Sees No Imminent Coronavirus Shortages

The Indian Pharmaceutical Alliance is working closely with the World Health Organization and International Generic and Biosimilar Medicines Association, as well as regional off-patent industry bodies in the US and Europe, to “navigate challenges on the manufacturing and logistics front” due to the coronavirus pandemic. Meanwhile, the IPA has welcomed domestic initiatives to boost API manufacturing.

India Coronavirus COVID-19
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Policy & Regulation Explore this Topic

Teva Sues FDA For Excluding Copaxone From BLA Transition

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Legal Issues Biosimilars

US Marks Biologics Transition Day

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Regulation Review Pathway

Reduction In Flights Hits Global Supply Chain

Urgent action is needed to reopen air freight routes so that the global off-patent industry can deliver critical medicines and supplies amid the coronavirus pandemic, international industry representatives have insisted.

Regulation International

FDA Scales Back Domestic Inspections Due To Coronavirus

After postponing foreign inspections, the US FDA has further decided to scale back domestic inspections due to the coronavirus outbreak.

Regulation Manufacturing

Ranibizumab SPC Cut By Nearly Two Years In UK

A ruling by the High Court has cut almost two years from UK SPC protection for Roche's Lucentis ranibizumab brand, potentially offering biosimilar competitors the change to jump into the market early.

Intellectual Property Biosimilars

UK Blocks 82 From Parallel Export

The UK government has added 82 items to its list of medicines that cannot be parallel exported from the country, including amoxicillin, insulin, paracetamol and several common proton pump inhibitors. The move comes as local off-patent industry association the BGMA has insisted that no short-term or medium-term shortages are foreseen amid the coronavirus pandemic.

Regulation United Kingdom
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Generic Drugs Explore this Topic

Cipla First On Generic Nexium Formulation

India’s Cipla has received the first US approval for a generic rival to Nexium delayed-release oral suspension in the US. The firm recently declared its intention to direct funds to more complex formulations in the US but nevertheless continues to grow its vast portfolio in the market.

Approvals Launches

Nivagen Raises Cash To Fuel Growth

California-based Nivagen is continuing to raise money to push through a number of generic launches in the US this year, the company’s founder and chief Jay Shukla told Generics Bulletin.

BioPharmaceutical Financing

Ibuprofen Concern Has Little Effect On UK Generic OTC Sales

Despite claims last week that ibuprofen worsened the effects of the coronavirus, prices of generic OTC versions of the drug have continued to rise in the UK, reflecting increased demand, according to market analysts WaveData.

Pricing Strategies Coronavirus COVID-19
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Biosimilars Explore this Topic

Teva Sues FDA For Excluding Copaxone From BLA Transition

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Legal Issues Biosimilars

Who’s Hired? Former Actavis Chief Bisaro Lands A New Role

Industry veteran Paul Bisaro has joined the board of TherapeuticsMD and Mylan has announced new Viatris appointments, while Amneal brings in a new CFO at the same time as Fresenius Kabi’s biosimilars head exits the company.

Appointments Strategy

Alvotech And DKSH Partner On Adalimumab In Asia

Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.

Deals Biosimilars
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Value-Added Medicines Explore this Topic

Who’s Hired? Former Actavis Chief Bisaro Lands A New Role

Industry veteran Paul Bisaro has joined the board of TherapeuticsMD and Mylan has announced new Viatris appointments, while Amneal brings in a new CFO at the same time as Fresenius Kabi’s biosimilars head exits the company.

Appointments Strategy

Bortezomib Booms For Stada As Russian Problem Remains

With group sales rising by double digits in 2019, Stada says it has the firepower to accelerate investment not only in the firm’s own product development but also broadly into external co-development and product in-licensing, to support sustainability and long-term growth.

Sales & Earnings Strategy

Who’s Hired? Endo Names New CEO

Endo has named a new CEO and CFO, while Mylan and Pfizer’s Viatris has found its CFO and announced its full roster of board members. Meanwhile, Assogenerici names the leaders of its value added medicines sector group, law firm Fish & Richardson gets a new CEO and France appoints a new health minister.

Appointments Generic Drugs
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