25 Jul 2019

Biohaven’s new drug fails to get FDA nod due to Apotex’s manufacturing problems

Last week, Biohaven Pharmaceutical Holding Company Limited said the US Food and Drug Administration (FDA) failed to approve its treatment for amyotrophic lateral sclerosis, or Lou Gehrig’s disease. The company said ...

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25 Jul 2019

Novartis’ sunny forecast for Sandoz; CEO sets aside US$ 700 million to settle bribery lawsuit

Swiss drugmaker Novartis has been busy overhauling its generics division — Sandoz. Over the last one year, Novartis has offloaded 300 underperforming generics in its oral solids and dermatology product lines to Aurobindo f...

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25 Jul 2019

Canada opposes US plans to import drugs; PhRMA steps up its lobbying spend

PharmaCompass has been routinely covering Trump administration’s efforts at tackling high drug prices. Earlier this month, there were reports that the administration is working on allowing the importation of cheaper drugs fr...

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25 Jul 2019

Pfizer’s Lyrica goes generic with 10 copycats; price down nearly 98 percent

Last week, the US Food and Drug Administration (FDA) approved the first generic versions of Pfizer’s blockbuster pain drug Lyrica (pregabalin). In this case, there was no 180-day exclusivity period for the first-to-fil...

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25 Jul 2019

WHO declares ebola emergency; Congo’s health minister resigns

Last week, the WHO Director-General Tedros Adhanom Ghebreyesus declared the Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo (DRC) a Public Health Emergency of International Concern (PHEIC). The PHE...

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25 Jul 2019

Appeals court upholds criminal conviction of Shkreli; Holmes, Balwani win order

In the US, a federal appeals court has upheld the criminal conviction of ‘pharma bro’ Martin Shkreli (36), who is serving a seven-year sentence in a federal prison in Pennsylvania. The panel in the US ...

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25 Jul 2019

WHO recommends dolutegravir as preferred HIV treatment

The World Health Organization (WHO) has recommended the use of HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential....

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25 Jul 2019

Sanofi buys OTC rights in US for Roche’s flu treatment Tamiflu

French drugmaker Sanofi has signed a rights deal with Roche for ‘Tamiflu’ in the United States. The deal gives Sanofi exclusive over-the-counter (OTC) rights to Tamiflu in the US. Tamiflu is used for the prevention...

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18 Jul 2019

FDA uncovers shredding of documents at Strides; Indoco gets another warning letter

India saw flagrant violations of current good manufacturing practices (cGMP) yet again. An FDA inspection of Strides Pharma Science Limited uncovered uncontrolled shredding of documents along with discarded cGMP documents. The ...

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18 Jul 2019

Indivior loses appeal to block generic Suboxone; Dr Reddy’s allowed to market drug

In the US, Indian drugmaker Dr Reddy’s Laboratories (DRL) got a shot in the arm as drugmaker Indivior Plc lost an appeal to block its generic Suboxone opioid treatment. A federal court ruled against Indivior in its bid to...

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