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Biocon Biologics Moves Quickly To Integrate Viatris In North America

 
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Biocon Biologics has announced the latest milestone in its integration of former partner Viatris’s biosimilars business, completing the move in the US and Canada “ahead of schedule.”

Global Pharma Guidance Tracker – Test sabbah

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: September 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – August 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Apotex Leans Into Brand Ambitions With Formosa Deal

 
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Apotex has made another move to bolster its burgeoning branded business, striking a deal with Formosa Pharmaceuticals for Canadian rights to its novel clobetasol propionate ophthalmic suspension.

Sandoz Debuts Denosumab Duo In Canada

 
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Sandoz has delivered the first denosumab biosimilar launch in Canada, introducing its Jubbonti and Wyost rivals to Amgen’s Prolia and Xgeva.

Canada Completes Biosimilar Switching Set With Manitoba Scheme

 
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Manitoba has become the tenth and final Canadian province to introduce a biosimilar switching scheme.

England Lags Behind Eight European Countries On Innovative Drug Availability

 

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

US Consumer Heath Market News: Trillium Sold, CRN Speakers, AG1 CEO, ChromaDex Counsel, More

 

Avista VC acquires OTC CMO Trillium; FDA deputy commissioner Jones to open CRN conference; AG1 founder steps down, COO moves up to CEO; ChromaDex hires general counsel; Ajinomoto, Shiru partner to develop sweet proteins; and change at ingredient provider LBB helm.

Health Canada Approves Two Formulations Of Celltrion’s Stelara Biosimilar

 
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Following past approvals for Alvotech and Amgen, Health Canada greenlighted Celltrion’s Stelara biosimilar in most of the relevant indications, moving it ahead of Alvotech’s product.

Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

 

Generics Bulletin reviews the latest regulatory events across the world.

Global Pharma Guidance Tracker – July 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Canada Expands Expedited Reimbursement Mechanism To Include All New Medicines

 

The rolling reimbursement reviews that Canada’s Drug Agency introduced as a pilot scheme to speed up patient access to COVID-19 products can now be used for any drug application. The move to open up the mechanism follows prompts by industry.

Global Medtech Guidance Tracker: July 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

Rejuvenated A Year Into Saunders’ Return To Helm, B+L Refreshing Blink, Lumify Lines

 

Brimonidine tartrate eye drops remain key sales driver among Canadian firm’s consumer health lines with 12% growth in the latest quarter. B+L expects pending launch of preservative-free line extension to sustain Lumify as a driver as generics of original formulation are approved.

Enhertu Snub From England’s NICE Not ‘In Line’ With Other Countries

 

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

US Wellness Market People News: Martha Stewart Supplements, Cheribundi Olympians, More

 

Martha Stewart sells supplements on iHerb; Cheribundi partners spread the brand at Paris Games; GoodSport’s latest partner is a Bear; Herbalife-sponsored runner competes in ultramarathons; Dutch researcher joins Unicity science board; and Beacon Wellness adds sales strategy chief.

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

 

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

 

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Global Pharma Guidance Tracker – June 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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