An In­di­an phar­ma with a man­u­fac­tur­ing site in Gu­jarat has been slapped with a Form 483 from the FDA af­ter in­spec­tions that end­ed yes­ter­day re­sult­ed in 10 ob­ser­va­tions.

The in­spec­tion was car­ried out from April 26 to May 9 at Sun Phar­ma’s Halol fa­cil­i­ty in Gu­jarat, and shares were down 3% fol­low­ing the re­lease of the news. The de­tails of the ob­ser­va­tions have not yet been re­vealed.

“The com­pa­ny is prepar­ing the re­sponse to the ob­ser­va­tions, which will be sub­mit­ted to the US FDA with­in 15 busi­ness days,” Sun Phar­ma said in a let­ter to the Na­tion­al Stock Ex­change of In­dia. “The com­pa­ny is com­mit­ted to ad­dress­ing these ob­ser­va­tions prompt­ly. The com­pa­ny re­mains com­mit­ted to work­ing close­ly with the US FDA and con­tin­ues to en­hance its GMP com­pli­ance on an on­go­ing ba­sis.”

An an­a­lyst told Busi­ness-Stan­dard that the site is re­spon­si­ble for rough­ly 5-6% of the com­pa­ny’s turnover and that the site has be­come small­er over the years.

Sun was forced to re­call 100,000 bot­tles of its gener­ic erec­tile dys­func­tion tablet back in Oc­to­ber. It al­so pulled more than 22,000 packs of ex­tend­ed-re­lease lo­rata­dine-D tablets. The site got hit with a Form 483 back in De­cem­ber 2019, when it was slapped with eight ob­ser­va­tions.

Just in March, the phar­ma was forced to pay a big set­tle­ment in lieu of claims of mis­con­duct against its Ran­baxy gener­ics unit. The phar­ma agreed to shell out $485 mil­lion to set­tle the class-ac­tion suit, with­out ad­mit­ting to the charges. Charges ac­cuse Ran­baxy of in­clud­ing false in­for­ma­tion in its ap­pli­ca­tions to make gener­ics of Genen­tech’s an­tivi­ral drug Val­cyte, No­var­tis’ Dio­van — which is used for blood pres­sure — and Nex­i­um, the acid re­flux drug from Pfiz­er. As a re­sult of the first ap­provals, the com­pa­ny gained 180 days of ex­clu­siv­i­ty on the mar­ket.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.