Medtech Insight RSS Feed - Commercial

US Shields Generics From Tariffs Amid Supply Chain Concerns

Dean Rudge — Fri, 03 Apr 2026 12:30:27 +0000

The Trump administration on April 2 imposed sweeping tariffs on imported pharmaceuticals following a year-long Section 232 national security investigation , while explicitly exempting generic and bio

‘It’s Day And Night’ – Haruvi On How The AAM Has Evolved

Dave Wallace — Fri, 03 Apr 2026 12:20:34 +0000

As chair of the Association for Accessible Medicines since late 2023, Keren Haruvi has helped to steer the US generics and biosimilars industry body through some turbulent times. Speaking to Generics

Hyloris Warns Valacyclovir Launch Could Slip Into 2027

Dean Rudge — Fri, 03 Apr 2026 12:20:20 +0000

Hyloris Pharmaceuticals has warned that its ready-to-use valacyclovir oral liquid program could face delays extending into 2027 following manufacturing setbacks tied to its US regulatory submission. T

GDUFA IV: US FDA Worries About Revenue Shortfalls, Industry Does Not

Derrick Gingery — Fri, 03 Apr 2026 12:19:53 +0000

The generic drug user fee program saw spending drop substantially in fiscal year 2025, but the US Food and Drug Administration remains concerned that revenue is not adequate and fee system changes are

Who’s Hired? Watson Returns As Apotex CEO

Dave Wallace — Thu, 02 Apr 2026 11:11:59 +0000

Apotex has announced that Jeff Watson has returned to his former role as the Canadian giant’s new president and CEO with immediate effect, following the decision of Allan Oberman to step down as chief

Teva Clarifies Operations Stable After Neot Hovav Strike

Dean Rudge — Thu, 02 Apr 2026 10:50:39 +0000

Teva has issued a clarification following recent reporting on missile activity near its local operations in Israeli, emphasizing that no company facilities were impacted and that business continuity h

Amarin Insists Skinny Labels Are Not A Safe Harbor

Dean Rudge — Thu, 02 Apr 2026 10:30:08 +0000

Amarin has urged the US Supreme Court to affirm the US Court of Appeals for the Federal Circuit’s decision in its long-running dispute with Hikma over skinny-label generics , arguing that “this case

Celltrion Streamlines Keytruda Biosimilar Trial Amid FDA Shift

Dean Rudge — Wed, 01 Apr 2026 10:49:33 +0000

Celltrion has moved to amend its Phase III clinical trial for its CT-P51 proposed biosimilar to Keytruda (pembrolizumab), in what appears to be a direct response to newly emerging regulatory flexibili

Regulatory Recap: ‘Predictability Is Essential’ For Pharma As Europe-Wide PFAS Ban Moves Forward

Urtė Fultinavičiūtė — Wed, 01 Apr 2026 10:49:17 +0000

The European Chemicals Agency’s Committee for Socio-Economic Analysis has released its draft opinion on the total ban of per- and polyfluoroalkyl substances, or PFAS, colloquially known as forever che

Teva’s Prolia Biosimilar Approved By US FDA As Xolair Rival Filings Accepted In EU And US

Urtė Fultinavičiūtė — Wed, 01 Apr 2026 10:38:21 +0000

The US Food and Drug Administration has approved Teva’s denosumab biosimilar rival to originator Prolia. To be marketed under the name Ponlimsi, the biosimilar is indicated for all bone conditions cov

What’s Next? Five Things To Look Out For In April

Dean Rudge — Wed, 01 Apr 2026 07:27:41 +0000

Farxiga LOE Opens US Generic Opportunity In April, AstraZeneca’s Farxiga (dapagliflozin) will reach a key loss-of-exclusivity milestone in the US, marking a pivotal moment for the SGLT2 inhibitor mark

Biosimilar Streamlining Takes A Further Step Forward In Europe

Dave Wallace — Tue, 31 Mar 2026 14:55:09 +0000

Almost a year to the day since the European Medicines Agency published a landmark draft reflection paper on streamlining the development and assessment of biosimilar medicines, the agency has formal

CapVest Hints At ‘Ambitious Plans’ For Stada As It Completes Takeover

Dave Wallace — Tue, 31 Mar 2026 13:49:44 +0000

CapVest has set out “ambitious plans” for Stada after completing its acquisition of a controlling majority stake in the German generics, biosimilars and consumer healthcare giant. Under a deal announ

US Supply Chain Challenges Increase In Shadow Of Iran War

Dave Wallace — Tue, 31 Mar 2026 11:04:27 +0000

As the war in Iran and the wider Middle East region continues with no clear end in sight, the US generics and biosimilars industry has become the latest off-patent sector to voice concerns over the im

Viatris Bets On Value-Added Medicines To Boost Growth

Dean Rudge — Mon, 30 Mar 2026 14:49:56 +0000

Viatris is sharpening its pivot toward value-added medicines and higher-margin products, laying out a more defined path to sustained growth through 2030 that builds on an advancing portfolio and ope

Neion Bio Strikes Initial Biosimilars Deal For Its Egg-Based Platform

Dave Wallace — Mon, 30 Mar 2026 13:53:24 +0000

Newly-launched biotech firm Neion Bio is founded on an eye-catching premise, and it isn’t underselling it: the company says it is “revolutionizing the production of biologic medicines” by using the la

Outlook Raises Cash As FDA Setbacks Cloud Future

Dean Rudge — Mon, 30 Mar 2026 10:30:46 +0000

Outlook Therapeutics has turned to a series of financing moves weeks after again acknowledging longstanding difficulties to secure US approval for its lead asset, an ophthalmic formulation of bevacizu

US FDA Seeks Higher Quality Responses To Form 483 Inspection Findings

Sue Sutter — Fri, 27 Mar 2026 16:45:05 +0000

A drug manufacturer’s response to an FDA Form 483 list of inspection observations should include a patient- and product-focused risk assessment of the findings, including possible safety, quality and

Henlius-Organon Denosumab Biosimilars To Enter Canada In 2026

Urtė Fultinavičiūtė — Fri, 27 Mar 2026 15:46:37 +0000

With Health Canada’s approval in its pocket, Shanghai Henlius Biotech said its two denosumab biosimilars will be marketed by its commercialization partner Organon “later this year.” The Chinese firm d

‘It’s Not A Question Of If, It’s A Question Of When’ – Sandoz’s Haruvi On US Biosimilar #1 Ambitions

Dave Wallace — Fri, 27 Mar 2026 12:18:06 +0000

Sandoz still has an ambition of becoming the number one market leader in biosimilars in the US – and according to the firm’s North America head Keren Haruvi, achieving this goal is only a matter of ti