Latest News in the pharma Industry

Policy & Regulation

FDA approves only triple-combination tablet with Jardiance

FDA approves only triple-combination tablet with Jardiance

31 Jan 2020

Trijardy XR is a once-daily therapy combining three well-established treatments in one pill.

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FDA approves Unidose device for new nasal seizure rescue treatment

FDA approves Unidose device for new nasal seizure rescue treatment

23 Jan 2020

The single-use, ready-to-use, one-step nasal delivery device can deliver a formulation in an emergency situation quickly and easily.

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Lupin could face FDA regulatory action over Tarapur API facility

Lupin could face FDA regulatory action over Tarapur API facility

13 Jan 2020

India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.

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2019, the year that got serialization done!

2019, the year that got serialization done!

17 Dec 2019

The past 12 months have been busy as many companies fought to comply with serialization regulations.

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Sartorius Stedim Biotech launches new Sartocheck 5 Plus filter tester

Sartorius Stedim Biotech launches new Sartocheck 5 Plus filter tester

21 Oct 2019

Highest level of data integrity as requested by regulatory authorities.

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FDA approves first  and only medicine in a new class of acute treatment for migraine

FDA approves first and only medicine in a new class of acute treatment for migraine

15 Oct 2019

The approval of Eli Lilly's Reyvow represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

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Unidose device approved for Tosymra sumatriptan spray

Unidose device approved for Tosymra sumatriptan spray

3 Oct 2019

Provides migraine sufferers with a convenient, patient-friendly delivery approach.

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EC approves its first plant-derived cannabis-based medicine

EC approves its first plant-derived cannabis-based medicine

24 Sep 2019

Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.

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Taiwan's biggest CDMO secures FDA approval

Taiwan's biggest CDMO secures FDA approval

3 Sep 2019

Customers claim Bora's oral solid dosage Zhunan facility is in the top 5 external manufacturing facilities they’ve ever visited in the world.

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FDA warns OTC drug manufacturer for drug manufacturing data integrity violations

FDA warns OTC drug manufacturer for drug manufacturing data integrity violations

21 Aug 2019

Company provided FDA investigators with multiple documents that were falsified.

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FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia

FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia

25 Jul 2019

Aptar’s nasal Unidose device - the result of a 10-year customer collaboration - marks the first FDA approval of a prescription drug using the company’s patented Unidose Powder System.

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Legacy ramps up preparations for new Russian track and trace sterilisation regulations

Legacy ramps up preparations for new Russian track and trace sterilisation regulations

18 Jul 2019

Company to install new inspection cameras with higher resolution to ensure readability of more complex codes demanded by the Russian mandated crypto coding.

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