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Manufacturing

Set Alert for Manufacturing

Merck As Anchor, Scale As Lever, Aurobindo Looks To Spar With Lonza, WuXi Group

Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.

Strategy Sales & Earnings

Olon Opens New R&D Site In Milan

Italy’s Olon has opened its new R&D hub in Milan, shortly after announcing plans to expand a key manufacturing facility in India.

Research & Development Ingredients

Turkey’s Abdi İbrahim Allies With mAbxience For ‘Unprecedented’ Technology Transfer

Five years after striking a biosimilars alliance with Iceland’s Alvotech, Turkish firm Abdi İbrahim – which boasts the country’s “largest biotech pharmaceutical manufacturing facility” – has shaken hands with Spanish developer mAbxience for technology transfer of an undisclosed oncology biosimilar.

Biosimilars Deals

Sandoz Opens Two European Sites, In Biosimilars And Antibiotics

Newly separated Sandoz has provided a trio of updates, foremost for its manufacturing and research ambitions for both biosimilars and antibiotics.

Biosimilars Manufacturing

Strides Sees $300m Peak Revenues From CDMO GLP-1 Partners, Sells Singapore Unit At Loss

Strides expects to meet an earlier forecast $250m in FY24 US revenues via new product launches and sees peak revenues of $300m from CDMO partners for GLP-1 products. Meanwhile, it has sold a deactivated Singapore facility at a net loss, ending up with an overall loss of $18m in the fiscal second quarter.

Strategy Sales & Earnings

US Biosimilars ‘Bumpy’ For Teva As It Prepares For Alvotech Inspection

Offering the latest details on Teva’s biosimilars strategy, CEO Richard Francis spoke about how the firm is looking to bring Alvotech’s FDA filings to the finish line as well as hinting at future biosimilars partnership deals. At the same time, he acknowledged a “bumpy” US market with a degree of uncertainty that has led the firm to allocate capital accordingly.

Strategy Biosimilars

Who’s Hired? Ananth Returns To Teva As New API Chief

Teva has announced that R. Ananthanarayanan – known as Ananth – is to rejoin the company as CEO of its active pharmaceutical ingredients business after taking leading roles at Cipla and Strides in recent years. Meanwhile, Strides has disclosed a change of chief operating officer coming next year, while Civica Rx has named a manager for its sterile injectables operations.

Executive Changes Leadership

Pharmascience Looks To Be Injectables Force With CAD120m Manufacturing Investment

Pharmascience CEO Martin Arès had suggested to Generics Bulletin that material investment was coming as the company looked to grow in its native Canada and shore up the local supply chain.

Manufacturing Companies

Supply Chain Confidentiality Doesn’t Stand 'Sunshine Test', Califf Says

US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.

Supply Chain Generic Drugs

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Generic Drugs Quality

Teva Offers Update On Operations In Israel

Amid war in Israel, local generics industry giant Teva has indicated that it sees no “meaningful impact” on its business from the conflict, while highlighting that it is prioritizing the importance of its employees and patients.

Israel Palestine

Alvotech Receives CRL From FDA Over Ustekinumab Filing

Alvotech has announced that, “as expected”, its US filing for its AVT04 ustekinumab candidate has resulted in a complete response letter from the FDA over manufacturing facility deficiencies, following similar knockbacks for its adalimumab biosimilar. However, the firm anticipates an inspection and a new goal date for the proposed Stelara rival long before its planned February 2025 launch date.

Biosimilars Complete Response Letters

Biocon Receives Another FDA Setback On Insulin Aspart

Biocon has announced receipt of another CRL from the FDA relating to its insulin aspart biosimilar application, after the agency failed to schedule a reinspection of the firm’s Malaysia facility ahead of the latest goal date.

Biosimilars Complete Response Letters

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Biosimilars Value-Added Medicines

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Manufacturing Generic Drugs

Glenmark Divests API Company, Setting Out On Distinct Journeys

Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”

Commercial M & A
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