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Teva Envisions ‘Significant’ Wait For US Price Fixing Cases

Teva said it was once again at the mercy of the COVID-19 pandemic as it forecasted an extended if not indefinite wait for both criminal and civil proceedings over alleged generic drug price fixing in the US to move to trial.

Legal Issues Generic Drugs

Coronavirus Spotlight


Coronavirus Spotlight

Industry Steps Up To Help India Through Second Wave

As India sees a consistent rise in daily cases and deaths due to COVID-19, the off-patent industry is stepping up to make drugs affordable and available. Zydus Cadila is seeking approval for virafin, while Natco has applied for molnupiravir approval. Vaccine production and availability has also come under focus. 

Coronavirus COVID-19 Generic Drugs

OUTLOOK 2021

In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies


VIEW 2021 RANKINGS

Entries Open For The Global Generics & Biosimilars Awards 2021

Entries are now open for the Global Generics & Biosimilars Awards 2021, which will take place in Milan, Italy on 10 November.

Generic Drugs Biosimilars Value-Added Medicines

Teva: Biosimilars In The US Will Become Like Complex Generics

With a couple of major partnerships and a stable of internal projects, Teva expects to play a role in the “majority of meaningful US biosimilar launches in the next five-to-eight years,” executive vice-president for North America commercial Brendan O’Grady told Generics Bulletin in an exclusive interview.

Biosimilars Commercial Strategy
 

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Pfizer Asks For Biden’s Co-operation To Incentivize Biosimilar Uptake

Pfizer is looking for the Biden administration’s co-operation to address the policy issue of affordability and access to biosimilars. In the first quarter, the company’s biosimilars segment grew by 84% on the back of new launches, especially in the US where biosimilars sales nearly doubled. 

Sales & Earnings Vaccines

Hyloris Pushes Into South America With Maxigesic IV

Hyloris is on a roll with licensing deals for its Maxigesic IV non-opioid pain treatment, with an extension of its existing agreement with Pharma Bavaria to cover South American territories coming hot on the heels of recent developments in the US and Europe.

Deals Value-Added Medicines

Teligent Announces $140m Operating Loss As Plant Woes Continue

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Sales & Earnings Strategy

Lannett Bets On Respiratory And Insulins Pipeline As Sales Falter

Despite turnover dropping by over a fifth in its financial third quarter, Lannett says it is optimistic that respiratory generics and insulins will offer the firm “durable” opportunities in future. The company has also just reorganized its finances to extend its debt maturity by four years, pushing it back past some of its key launches.

Sales & Earnings Strategy

Laurus Labs Expands Capacity To Meet API Demand

Laurus Labs has reported a 70% jump in annual revenues after what the company described as an “extraordinary year.” The firm has decided to expand its current capacities to meet the increased demand for third-party API sales and is looking to file eight to ten ANDAs next year as it sees “many long-term opportunities in the US generics space.”

Generic Drugs Strategy

Samsung Bioepis Nudges Closer To Ranibizumab Approvals With New Data

Samsung Bioepis has been tight-lipped on the potential to win approval for its SB11 biosimilar ranibizumab product this year, though new similarity data is a further positive omen for the Korea-based biosimilar player.

Biosimilars Clinical Trials
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Policy & Regulation Explore this Topic

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Korea To Toughen Co-Bioequivalence Study System

Legislation that could thin the crowded generic market clears first parliamentary hurdle as brand and generic firms alike react to the recent generic quality issue raised by recent manufacturing incidences at some South Korean pharma firms.

Legislation Generic Drugs

Alberta Expands Biosimilar Switching With Adalimumab

Alberta has become the latest Canadian province to expand its biosimilar switching program to cover adalimumab biosimilars to Humira.

Canada Biosimilars

New Supplement Timelines, Categories Proposed For BsUFA III

The ideas could potentially address sponsor concerns about the effects of slow reviews.

Biosimilars User Fees

BsUFA III Talks Begin With Regulatory Science Disagreement

Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.

Biosimilars User Fees

UK Could Become ‘World Leader’ On Biosimilar Regulation

The UK is putting itself in a position to play a leading role in global biosimilars regulation, thanks to a proposed new registration pathway that will not require comparative efficacy data, delegates to a Westminster Health Forum online conference heard earlier today.

Biosimilars Regulation

AAM Backs Bill To Boost Biosimilar Reimbursement

Draft US legislation that would seek to encourage biosimilar adoption by temporarily boosting reimbursement has received the backing of the AAM.

Biosimilars Reimbursement
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Generic Drugs Explore this Topic

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Teva Envisions ‘Significant’ Wait For US Price Fixing Cases

Teva said it was once again at the mercy of the COVID-19 pandemic as it forecasted an extended if not indefinite wait for both criminal and civil proceedings over alleged generic drug price fixing in the US to move to trial.

Legal Issues Generic Drugs

Teligent Announces $140m Operating Loss As Plant Woes Continue

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Sales & Earnings Strategy

Korea To Toughen Co-Bioequivalence Study System

Legislation that could thin the crowded generic market clears first parliamentary hurdle as brand and generic firms alike react to the recent generic quality issue raised by recent manufacturing incidences at some South Korean pharma firms.

Legislation Generic Drugs
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

Pfizer Asks For Biden’s Co-operation To Incentivize Biosimilar Uptake

Pfizer is looking for the Biden administration’s co-operation to address the policy issue of affordability and access to biosimilars. In the first quarter, the company’s biosimilars segment grew by 84% on the back of new launches, especially in the US where biosimilars sales nearly doubled. 

Sales & Earnings Vaccines

Australia Extends Biosimilar Education Efforts

Australia’s government has agreed to extend a successful biosimilar education initiative led by the local GBMA industry association.

Australia Biosimilars

Alberta Expands Biosimilar Switching With Adalimumab

Alberta has become the latest Canadian province to expand its biosimilar switching program to cover adalimumab biosimilars to Humira.

Canada Biosimilars
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Hyloris Pushes Into South America With Maxigesic IV

Hyloris is on a roll with licensing deals for its Maxigesic IV non-opioid pain treatment, with an extension of its existing agreement with Pharma Bavaria to cover South American territories coming hot on the heels of recent developments in the US and Europe.

Deals Value-Added Medicines

Hyloris And Hikma Ally On Maxigesic IV In US

Hyloris has secured Hikma as its US marketing partner for Maxigesic IV. The deal gives Hyloris access to Hikma’s presence in complex, injectable hospital products while aligning with Hikma’s push into differentiated treatments.

Deals Value-Added Medicines

Estetrol Approvals Mark 'Turning Point' For Mithra

Recent Canadian, European and US endorsements of Mithra’s estetrol-based Estelle novel oral contraceptive mark a “turning point” for the Belgian firm, which has also seen success with its Myring generic rival to NuvaRing for which it expects to see further launches this year.

Strategy Generic Drugs
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