Ru­mors of bad news can flick­er around the BioTwit­ter world in a heart­beat. And the im­pact can be dev­as­tat­ing.

On Tues­day the tar­get was In­tra-Cel­lu­lar Ther­a­pies $IT­CI, and the ru­mor was pegged to an up­date on the FDA’s web­page that not­ed the agency was can­cel­ing the Psy­chophar­ma­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee meet­ing for Ju­ly 31 and the re­view planned for the biotech’s schiz­o­phre­nia drug, lu­mate­per­one to­sy­late cap­sules.

For the le­gions of in­vestors look­ing for some­thing, any­thing, on the in­ter­net to bet on with what might be an in­side clue to a cat­a­lyst, it was pure gold. Had reg­u­la­tors al­ready de­cid­ed against the drug? What could it mean? It had to be bad, right?

Dis­as­ter!

The com­pa­ny’s stock was shred­ded, drop­ping more than 30% on the spec­u­la­tion. More than $150 mil­lion in mar­ket cap was gone in a snap as word of the move spread.

Then, af­ter the mar­ket closed, In­tra-Cel­lu­lar tried to staunch the flow of red. The biotech put out a state­ment say­ing that they had sup­plied ad­di­tion­al in­for­ma­tion on their drug that the agency want­ed ex­tra time to study — hence the de­ci­sion to strike the ad­comm.

The FDA can­celled the Ad­vi­so­ry Com­mit­tee meet­ing to al­low suf­fi­cient time to re­view this new and any forth­com­ing in­for­ma­tion as they con­tin­ue the NDA re­view.  This in­for­ma­tion may re­sult in an ex­ten­sion of the Sep­tem­ber 27, 2019 Pre­scrip­tion Drug User Fee Act (PDU­FA) tar­get ac­tion date for the lu­mate­per­one NDA.

That was good for a 9% re­bound af­ter the bell on Tues­day.

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

The FDA on Monday said it updated its recommendations for the clinical development of new antibacterial drugs, and thanks to a new clutch of drugs, sponsors will have to conduct noninferiority trials that include subjects with infections caused by certain drug-resistant organisms because an effective active control can be provided.

The guidance, which is likely to be released within the next day or so, builds on a 2017 document and specifies what noninferiority trial designs may be used “with a wider NI margin,” including cases in which the trial population is enriched for subjects with infections caused by certain drug-resistant organisms, FDA said.

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.

Bristol Myers Squibb is bringing new life to a chemotherapy drug from the old Celgene pipeline as it touts another approval in a rare form of blood cancer affecting young children.

The FDA on Friday approved Vidaza (chemically known as azacitidine) for pediatric patients 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML). The new indication marks the first approval for Vidaza in more than a decade, though it’s commonly used to treat acute myeloid leukemia and myelodysplastic syndromes (MDS).

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.

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.