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Teva Has Nasal Naloxone Nod For First US Narcan Rival

Teva has received FDA approval for the first US generic naloxone nasal spray after a 30-month stay linked to ongoing patent litigation expired. Launch plans have not yet been revealed. Meanwhile, the Israeli firm has also introduced the first generic version of VESIcare in the US.

Regulation Generic Drugs United States

Hexal Seizes On Opportunity Of German Levocetirizine Switch

A prescription-to-OTC switch for levocetirizine has opened the door for generic producers such as Sandoz’ Hexal to extend their consumer healthcare allergy offerings in Germany.
Prescription To Otc Switch Germany Launches

Sandoz Accuses United Therapeutics Of Blocking Generic Remodulin

A Sandoz lawsuit has accused United Therapeutics of trying to illegally block sales of the first US generic version of Remodulin.

Legal Issues Generic Drugs United States
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Piramal’s Sensipar Generic Is Blocked In The US

Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.

Generic Drugs Legal Issues

Abbott Sees Emerging Markets Fundamentals Staying Strong

Abbott sees solid market dynamics in its core emerging markets for branded generics, including in India, Brazil, Russia and China.
Sales & Earnings Business Strategies

Novartis Selects GSK’s Saynor As Next Sandoz CEO

GlaxoSmithKline’s established products head, Richard Saynor, will return to Sandoz later this year to lead the Novartis division.
Appointments Leadership

Aceto Completes Sale Of Rising Pharmaceuticals

Aceto has completed the divestment of its Rising Pharmaceuticals generics unit, is moving ahead with the disposal of its chemicals business and has disclosed a bonus incentive scheme for its CEO, William Kennally, aimed at securing the maximum value for its assets as part of bankruptcy proceedings.

Deals Strategy

People Round-Up: Bhadauria Named As Amneal CSO

Amneal gets a new CSO, Acino restructures its board under a new chair, the AAM adds an assistant general counsel and the British Biosimilars Association names a vice-chair, as well as other people movements from around the generics, biosimilars and value-added medicines industries.

Appointments Strategy

MS Pharma Acquires Genepharm In Expansion Push

MS Pharma, a leading generics company in the Middle East, has announced an agreement to acquire Greece-based Genepharm as part of an expansion drive into Europe and farther afield.

Deals Strategy
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Policy & Regulation Explore this Topic

Greater Clarity Needed On CGT Pathway In US

Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.

Policy & Regulation Regulation

European Parliament Passes SPC Manufacturing Waiver

A waiver to allow manufacturing of generics and biosimilars during the term of supplementary protection certificates is on the verge of being realized after the European Parliament approved the Regulation by a large majority.

Intellectual Property Europe

Aurobindo In Trouble Again With FDA, Gets Form 483 With 11 Observations

The US Food and Drug Administration has flagged more problems at Aurobindo, issuing another Form 483 to the company over one of its plants in southern India. This one, containing 11 observations, sharply faults quality controls.

Manufacturing Regulation

Value-Added Oncology Round-Up: Foresee Files In US For Leuprolide

Foresee is seeking a US commercial partner for the long-acting leuprolide it has just filed in the US; Sun has launched ready-to-infuse gemcitabine in the US as the first in an intended line of pre-mixed cancer therapies.
Value-Added Medicines Cancer

FDA Lists Impurity-Free Valsartan And Other ARB Drugs

In the wake of impurities being discovered in certain valsartan and other ARB drugs, the FDA has published a list of known nitrosamine-free examples of these medicines as part of ongoing efforts to address the issue.

Generic Drugs Policy & Regulation

US Ambrisentan Approvals Hint At Different Commercial Approaches

Four different firms have simultaneously received FDA approval for ambrisentan generics of Gilead’s Letairis. But different safety programs suggest Zydus Pharma may be taking a different commercial approach to the other three generics firms.
Drug Safety Approvals
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Latest From Generic Drugs

Two US OxyContin Patents Are Found To Be Invalid

Prior-art references render two US formulation patents protecting OxyContin unpatentable as obvious, a Court of Appeals has confirmed.


Intellectual Property United States

Piramal’s Sensipar Generic Is Blocked In The US

Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.

Generic Drugs Legal Issues

Greater Clarity Needed On CGT Pathway In US

Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.

Policy & Regulation Regulation
See All

Latest From Biosimilars

Novartis Selects GSK’s Saynor As Next Sandoz CEO

GlaxoSmithKline’s established products head, Richard Saynor, will return to Sandoz later this year to lead the Novartis division.
Appointments Leadership

US Oncologists See Biosimilars As An ‘Appealing Alternative’

US community oncology practices are keen to support biosimilar uptake. But they appreciate the need to educate physicians not only on the biosimilar approval pathway, but also on commercial realities in the market.
Biosimilars Cancer

People Round-Up: Bhadauria Named As Amneal CSO

Amneal gets a new CSO, Acino restructures its board under a new chair, the AAM adds an assistant general counsel and the British Biosimilars Association names a vice-chair, as well as other people movements from around the generics, biosimilars and value-added medicines industries.

Appointments Strategy
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Latest From Value-Added Medicines

Value-Added Respiratory Round-Up: Cipla Teams With Pulmatrix For Itraconazole

Cipla has struck a deal for dry-powder itraconazole and has also launched a fine-particle beclometasone/formoterol inhaler in India.
Value-Added Medicines Respiratory

Lack Of Lilly Litigation Clears Path For Pfenex’ Forteo Rival

Pfenex says it can now launch its teriparatide in the US upon FDA approval, after Lilly failed to file a lawsuit in reaction to a Paragraph IV challenge to a Forteo device patent within the statutory timeframe.

Launches Generic Drugs

Value-Added Schizophrenia Round-Up: Luye Expects Chinese First With US Risperidone

Several firms are making progress on added-value risperidone formulations: Luye Pharma anticipates FDA approval for its extended-release microspheres; Rovi is moving towards a US 505(b)(2) filing for its Doria once-monthly formulation; and Indivior has introduced its Perseris subcutaneous suspension in the US.
Value-Added Medicines United States
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