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Set Alert for Manufacturing

Hikma Strikes $185m Deal For Xellia Injectables Portfolio, Manufacturing Facility

Hikma is not resting on its laurels after paying $375m upfront for US injectables specialist Custopharm two years ago, penning another acquisition agreement for a bundle of pharma and physical assets from Danish firm Xellia.

M & A Deals

Xbrane Welcomes Milestone In $14bn Nivolumab Journey, Partner Sought

In a for-now limited pool of chasers, Sweden’s Xbrane Biopharma has unveiled a milestone and business update for its proposed biosimilar to Bristol Myers Squibb’s major PD-1 inhibitor, Opdivo.

Biosimilars Manufacturing

Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

Manufacturing Regulatory

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Manufacturing Reimbursement

Duo Falter Again On US Belbuca ANDA, Eight Years After Joining Hands

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Complete Response Letters Generic Drugs

Bora Completes Upsher-Smith Takeover

Bora Pharmaceuticals has completed its takeover of Upsher-Smith from Sawai, with the acquisition opening up new US opportunities for the Taiwanese company including providing the firm with its first US manufacturing sites.

Deals M & A

Open For Business: Sandoz’s Austrian Antibiotic Facility Is Ready To Serve

As Sandoz continues to fight against antimicrobial resistance, the firm opens a new production facility in Austria, strengthening its position in Europe with a vertically integrated production network for penicillin.

Generic Drugs Manufacturing

Alvotech Willing And Able To Go Stride For Stride On Pembrolizumab Manufacturing

Alvotech stepped into its 2023 annual financing results call bursting with positive news and momentum, on the back of obtaining USFDA approval for its biosimilar Humira product and a bullish outlook for its strong pipeline of biosimilar candidates.

Biosimilars Manufacturing

‘Potential Misconduct’ Shuts EuroAPI Plant In Italy As 2024 Guidance Suspended

EuroAPI is on the backfoot once again after being forced to suspend production at its manufacturing site in Brindisi, Italy, weeks after unveiling a four-year strategic roadmap that sought to tighten and focus its operations amid a challenging two years.

Manufacturing Quality

Canadian Industry Remains Apprehensive About Pharmacare Reform

Although the two Canadian off-patent industry bodies support new initiatives that expand drug coverage for Canadians, they remain cautious about the use of pricing schemes that could potentially affect drug supply of generics.

Canada BioPharmaceutical

AMR Industry Alliance Calls Out UN For Urgent Steps

Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance.

International Infectious Diseases

Fresenius Divests Norwegian Plant To Prange

Fresenius Kabi has completed the divestment of a manufacturing plant in Halden, Norway, to Prange Group.

Manufacturing Deals

Richter Takes Control Of German JVs To Wrap Up Teriparatide Biosimilar

Gedeon Richter is putting its hand back in its wallet following its recent investment in Formycon, opting to take control of a pair of joint ventures established with German firm Helm.

M & A Deals

KVK Research Pleads Guilty To Adulterated Drug Distribution

KVK Research and KVK Tech failed to notify the US FDA about the use of a foreign API manufacturing facility and submitted alleged false claims to governmental health programs.

Compliance Generic Drugs

Mark Cuban’s Company Will Manufacture Own Drugs To Combat Drug Shortages

Powered with robotic and artificial intelligence technologies, Mark Cuban’s Cost Plus Drug Company aims to manufacture drugs in shortage and bypass pharmacy benefit managers.

United States Generic Drugs

Sawai Reports Slight Growth In Japan Amid Challenges

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Sales & Earnings Manufacturing
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