It’s start­ing to feel like Te­va $TE­VA can’t catch a break. Af­ter an in­cred­i­bly rough se­ries of events that led to mas­sive lay­offs, re­struc­tur­ing, and po­lit­i­cal up­heaval, now Te­va has qui­et­ly sig­naled to in­vestors that the launch of its CGRP mi­graine med could be de­layed.

Te­va’s stock has tum­bled near­ly 10% in pre-mar­ket trad­ing on the news.

Te­va’s drug, called fre­manezum­ab (TEV-48125), came up with some im­pres­sive Phase III da­ta last fall, with 41% of pa­tients on their CGRP drug see­ing their mi­graine days cut in half, com­pared to 18% on the place­bo. The dou­ble blast of da­ta un­der­scores the late-stage race to reg­u­la­tors as some big and small play­ers an­gle for a slice of the new CGRP mi­graine mar­ket.

But now, fre­manezum­ab may hit a stum­bling block. Te­va’s part­ner Cell­tri­on, which man­u­fac­tures an ac­tive in­gre­di­ent in fre­manezum­ab, re­ceived a warn­ing let­ter from the FDA rais­ing is­sues over a man­u­fac­tur­ing fa­cil­i­ty in In­cheon, South Ko­rea.

The slow­down couldn’t come at a worse time for the com­pa­ny, as ri­vals Am­gen $AMGN and its part­ner No­var­tis $NVS were al­ready in the lead to com­mer­cial­ize their own CGRP mi­graine drug, Aimovig. The FDA has al­ready ac­cept­ed Am­gen’s ap­pli­ca­tion for Aimovig — hand­ing the com­pa­ny a PDU­FA date of May 17.

The CGRP field is grow­ing hot, with a line­up of de­vel­op­ers po­si­tion­ing their own late-stage prod­ucts for the last leg of the race.

Ear­li­er this year, Eli Lil­ly $LLY cel­e­brat­ed its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front. Lit­tle Alder $AL­DR is plan­ning to join the com­mer­cial fight with their drug, as well. Then there’s Bio­haven $BHVN, which re­cent­ly in-li­censed a sim­i­lar drug from Bris­tol-My­ers Squibb and scored a very suc­cess­ful IPO ear­li­er this year.

Te­va not­ed the warn­ing let­ter on a slide for in­vestors, and said the com­pa­ny was “in ac­tive di­a­logue with the FDA in an ef­fort to main­tain our pri­or­i­ty date for the ap­proval.”

Typ­i­cal­ly takes 16-18 months to re­solve an FDA warn­ing let­ter, $TE­VA says. Com­pa­ny planned to have two API sup­pli­ers but the sec­ond sup­pli­er isn’t ready yet, Schultz says

— Em­ma Court (@em­mar­court) Feb­ru­ary 8, 2018

CEO Schultz says $TE­VA is hop­ing to work with FDA on franezum­ab CGRP ap­pli­ca­tion be­cause Cell­tri­on warn­ing let­ter was for fin­ished prod­ucts, not API. A sec­ond API sup­pli­er is in the works but not ready to go. Good news for ri­val $NVS

— Jes­si­ca Mer­rill (@Jes­si­cae­mer­rill) Feb­ru­ary 8, 2018

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

→ Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.