A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.
Aiming to encourage entry of generic drugs on the market, the US FDA published a finalized guidance that regulates processes for relevant designations and expedited approvals.
Amneal announces acquisition of 65.1% majority interest of generics distributing company, AvKARE, boosting its presence in the generics and federal healthcare market.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
Generics drug portfolios are diversifying, prices are stabilising, and while competition remains intense, the worst of price erosion appears to be over, claims Clarivate Analytics executive.
The US Court of Appeals for the Federal Circuit removed the injunction against Dr. Reddy’s, which prevented the company from selling its Suboxone generic.
Agilent Technologies says changes in the industry this year will present opportunities for continued growth in its pharma processing equipment and consumables business.
Teva Pharmaceutical Industries will reduce its workforce by 14,000, rejig its generics portfolio and speed up optimization of its plant network as part of a $3bn (€2.5bn) cost saving plan.
Teva Pharmaceutical Industries Ltd has confirmed its API plant in Netanya, Israel will close as part of the cost reduction programme announced last week.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.
Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.
Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.
Private equity fund Apax Partners will take control of Spanish API manufacturer Inke when it completes the acquisition of Invent Farma later this year.
VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.
When pharmaceutical companies miss their capacity forecast, it is both costly and time consuming, so many are choosing to outsource in order to mitigate risks.
DCAT Week, which will be March 14-17 in New York, is organized by the Drug, Chemical & Associated Technologies Association (DCAT), and brings together key players from across the industry.
The new report indicates that the US CMO market is poised for significant growth and urges international companies to enter the market – or be left behind.
Many generic drugs are not truly bioequivalent to the original medicines they copy and switching to them can lead to worse patient outcomes, according to US researchers.
Clariant will build a CHF10m ($9.7m) moisture control device plant in Cuddalore, Tamil Nadu to cater for the branded and generic drugmakers operating in India.
In the second setback for Dr Reddy’s within a week, the District Court of Delaware has granted a temporary restraining order preventing the company from selling esomeprazole, the generic version of AstraZeneca’s Nexium.
"People are the essence of the company going forward," said Teva, referring to the news that the world's largest generic drug maker will purchase Allergan's generics business for $40.5bn, at its Q2 financial results press conference...
Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.
