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Thursday, May 6, 2021

NYC Pitches Free Vaccines for Tourists in Bid to Speed Recovery

 New York City wants to roll out mobile vaccination sites for visiting tourists as the five boroughs look to revive their vibrancy post-pandemic, Mayor Bill de Blasio says.

De Blasio described the program, which would target tourists with free Johnson & Johnson doses at popular attractions, leaving them fully vaccinated (though not yet immune) to enjoy their stay in the city and reap the benefit of convenience.

The mayor says the state needs to modify the rules around vaccination a bit to approve the administering of shots to non-New Yorkers who don't work here, but he said his team was working with Gov. Andrew Cuomo's administration to get it done.

De Blasio says the mobile vans are ready to roll out as early as this weekend at spots ranging from the Empire State Building and Times Square to Brooklyn Bridge Park, the High Line and Central Park, among others, pending the state's green light.

"This is a positive message to tourists. Come here, it's safe, it's a great safe to be and we're gonna take care of you," de Blasio said. "We're going to make sure you get vaccinated while you're here with us."

The push to vaccinate tourists comes as the city looks to recover about $60 billion worth of economic contributions from tourism, according to state estimates and bring back nearly 90,000 industry jobs that were lost at the same time. Much of the city's revenue relies on out-of-town traffic, and that could get another boost soon, too.

A handful of Broadway productions resumed ticket sales early Thursday after Cuomo greenlit a full capacity reopening of the Great White Way by mid-September, while others, including some of the most iconic shows, joined within hours.

"Wicked," "The Lion Kings" and "Aladdin" are among the biggest productions already selling tickets. See our rolling list here. Some smaller productions may need more time to get their scheduling in order after the year-plus shutdown.

Broadway first suspended shows on March 12, 2020, as the city -- and nation -- reeled from the pandemic. At that time, 31 productions were running, including eight new shows in previews. Another eight were preparing to open in the spring.

It's not clear how many of the shows in previews or rehearsals will still be able to make their debuts. Refunds and exchange policies will be in place if any given performance has to be postponed suddenly because of a public health condition.

There will also likely be changes to the theater-going experience like the addition of contactless services, said Broadway League President Charlotte St. Martin.

"Broadway’s back. New York City’s back. Get ready," Mayor de Blasio tweeted just before ticket sales opened up early Thursday.

Prior to the pandemic, nearly 250,000 people were seeing a Broadway show every week.

It's not clear how quickly the seats will be filled to full capacity again as an anxious public looks to restore some semblance of normalcy to its collective post-pandemic life. But the Broadway League has said it eagerly anticipates reopening as much as millions upon millions of global fans look forward to getting back to its iconic stage.

While productions, theaters and attendees must adhere to state health guidance like masks and air filtration, Cuomo said theaters (and theater-goers) will be flexible to potential changes as New York's COVID situation -- and that of the country -- improves.

"It's going to cost millions to get a show up. I will be curious to see who will take that chance," said musical producer Glen Kelly, who has worked on shows like "Book of Mormon" and "Aladdin."

But Kelly, like other theater workers who have waited more than a year to get back to the stage, has some lingering questions.

"I hear about vaccination passports. No one seems to know how that would work," Kelly added. "No one seems to know are the audiences in masks? Is the backstage staff in masks? Do the performers wear masks and take them off before they come on stage?"

https://www.nbcnewyork.com/news/coronavirus/broadway-theaters-resume-ticket-sales-for-100-fall-return-but-how-many-will-fill/3039919/

Merkel Breaks With Biden, Opposes WTO Plan To Waive Vaccine IP Protections

 Stocks are surging Thursday on reports that German Chancellor Angela Merkel has reportedly announced that she will oppose a proposal to waive IP protections for COVID-19 vaccines. The decision represents a major break with the Biden Administration, perhaps the biggest rift between Berlin and Washington since President Trump left office.

  • MERKEL OPPOSES BIDEN PLAN TO WAIVE CORONA VACCINE PATENT

According to a spokeswoman, the plan would create "severe complications" for the production of vaccines, according to German government spokeswoman. Biden's top trade rep revealed yesterday that the White House had decided to back the proposal for a waiver at the WTO, breaking ranks with a host of developed countries to join a host of developing nations in a conflict between rich and poor nations.

Shares of vaccine makers and biotech stocks more broadly sold off on news that Biden was backing the waiver. But they've bounced back on reports of Merkel's opposition. The Nasdaq biotech stocks trimmed their losses, leading the index higher, while Moderna erased some of its losses.

The news dragged US stocks higher, reversing the losses triggered by news of Biden's support for the proposal, which was originally put forward by India and South Africa. The countries are pushing for resolution of the issue by December.

Analysts at BofA pointed out that waivers are "not an existential threat.." but instead a "relatively modest threat" for the biotech sector given: (1) high barriers to vaccine development.. (2) a short window for competitors to contribute to supply given that $PFE $MRNA expect to .. produce >9B doses by YE22 .."

It still remains to be seen whether other major developed powers, like Japan, Norway and the UK, will weigh in on the proposal.

https://www.zerohedge.com/markets/merkel-breaks-biden-opposes-wto-plan-waive-vaccine-ip-protections

Lilly in smart insulin pen deals with Roche, Dexcom and more

 To make sure its upcoming connected insulin pen system will work with the user’s choice of daily diabetes management platforms, Eli Lilly & Co. has signed compatibility agreements with four international providers.

That includes glucose monitoring sensors, digital health programs and other tools from Roche, Dexcom, Glooko and myDiabby Healthcare. 

Lilly is developing its Tempo Smart Button—a small device that attaches to its currently available, prefilled Tempo insulin delivery pen—to automatically record medication usage and wirelessly pair with smartphones or other devices. 

The company aims to secure a CE mark for the Tempo Smart Button by the end of this year, enabling it and the Tempo Pen to be sold as a single package in European markets.

"Insulin dose logging is often an incomplete piece of the diabetes management puzzle for people who use insulin pens and manually track their doses,” Lilly’s VP of product development for connected care and insulins, Marie Schiller, said in a statement.


Lilly is also leaving the door open for future collaborations, with the goal of making real-time data from its insulin pen easily accessible, Schiller said.

With Roche, the Tempo Smart Button will be able to beam data directly to the Big Pharma’s mySugr app, which syncs therapy and blood sugar information, while also tracking meals and exercise. The app, which also integrates with Novo Nordisk’s smart insulin pen, transmits comprehensive reports to healthcare providers through Roche’s diabetes care platform.

"Having diabetes is often described as a full-time job,” said Marcel Gmuender, global head of Roche Diabetes Care. “The time spent on activities that come with insulin therapy—blood glucose monitoring, carbohydrate counting, injections and lifestyle planning—can add up to several hours a week."


myDiabby, based in France, also provides telemedicine support to people with diabetes, with separate mobile apps for Type 1, Type 2 and gestational diabetes. Meanwhile, Glooko's virtual management platform is designed to connect with just about any diabetes device to offer remote monitoring.

"Studies have shown that when smart insulin devices are synced with digital health tools, it improves outcomes for people living with diabetes,” said Russ Johannesson, CEO of Glooko.

Lilly has also been collaborating with the glucose monitor maker Dexcom for years, integrating the company’s CGM systems with its pen- and pump-based insulin delivery platforms for personalized care. Last October, the two companies partnered up to co-promote Lilly’s Lyumjev fast-acting insulin alongside Dexcom’s G6 blood sugar sensor.

https://www.fiercebiotech.com/medtech/lilly-inks-smart-insulin-pen-deals-roche-dexcom-and-more

Bluebird names oncology spinoff, establishes leadership team

 Bluebird bio has disclosed the name of its oncology spinoff: 2seventy bio. The spinoff is taking cancer therapies and some executives, including the CEO and chief scientific officer, from bluebird.

Massachusetts-based bluebird first shared details of its plans to spin off its cancer assets into a new publicly traded company in January. Bluebird framed the separation as the way to best support both its cancer and rare disease assets given differences in the expertise needed to develop, manufacture and win approval for candidates in each space. 

Now, bluebird has shared an update on its plans, revealing both the name of the oncology spinoff and the thinking behind the moniker. 

“Two hundred seventy miles per hour is the maximum speed of human thought,” bluebird CEO Nick Leschly said in a statement. “The name 2seventy was selected to signify this speed and our team’s translation of thought to action as we advance our next generation pipeline of transformative cell therapies to help cancer patients urgently in need.”

As previously disclosed, Leschly will serve as CEO of the oncology spinoff, leaving Andrew Obenshain, the current president of the rare disease unit, to run bluebird. Leschly has now shared the names of some of the bluebird employees who will join him at 2seventy.

Philip Gregory, currently chief scientific officer at bluebird, will take on the same title at 2seventy. Gregory will be joined at 2seventy by Nicola Heffron, who holds the title chief operating officer, oncology, at bluebird. Heffron will fill the COO post at 2seventy. The C-suite is rounded out by Chip Baird, who will become chief financial officer at 2seventy having held the same post at bluebird.

The team will work to oversee development of a pipeline that features clinical trials of Abecma, the anti-BCMA CAR-T that recently won FDA approval, and earlier-stage assets. The other clinical-phase assets include an anti-MCC1 engineered TCR and BB212172, a twist on Abecma designed to have a lower proportion of highly differentiated or senescent T cells. 

At bluebird, Obenshain will be joined in the C-suite by executives including Rich Colvin, M.D., Ph.D., who will work as interim chief medical officer. Colvin joined bluebird from Novartis in 2018 and heads up clinical R&D in severe genetic diseases.

https://www.fiercebiotech.com/biotech/bluebird-names-oncology-spinoff-establishes-leadership-team

Becton to spin off $1B diabetes care business into standalone public company

 After nearly a century spent building out its portfolio of insulin pens and syringes, BD is finally ready to let its diabetes care business leave the nest.

While reporting financial results for the second fiscal quarter of the year, during which revenues grew more than 15% to $4.9 billion, BD also laid out its plans to spin off its diabetes-focused segment.

The split is expected to be completed in the first half of 2022, after which the segment will become a completely separate, publicly traded company, tentatively dubbed "NewCo."

The independent venture will be based in New Jersey and Massachusetts, with manufacturing sites throughout the U.S., Ireland and China. It will be led by CEO Devdatt Kurdikar, who joined BD in February as president of BD Diabetes Care, and Chief Financial Officer Jacob Elguicze, who joined BD this month and is the former treasurer and head of investor relations for Teleflex.

The new company will aim to build on BD’s established footprint in the diabetes care market, where it reported revenues of nearly $1.1 billion for fiscal year 2020. BD currently produces around 8 billion injection devices each year for 30 million patients, leaving plenty of room for NewCo to expand operations to reach the approximately 463 million people around the world with diabetes.

The company said isolating its diabetes business will give it the space it needs to accumulate the resources and leadership necessary to meet the rising global demand for insulin delivery devices.

“I am fully confident that, as a standalone business, NewCo will have the flexibility to invest in the right areas to become a more nimble, agile and innovative company in the rapidly growing diabetes space,” Kurdikar said in a statement.


BD, meanwhile, will be able to provider a greater focus on its other core business areas, including in its life sciences and interventional divisions, as well as the remainder of its diabetes programs' former home, BD Medical.

Going forward, the company said it hopes to redouble its efforts across three categories: use advanced technology such as artificial intelligence and robotics to improve care; establish new points of care to enhance the patient experience and save on costs; and increase investments in the development of diagnostics and treatments for chronic diseases.

“The spinoff will allow BD to strengthen its growth profile, enables a greater investment focus on our other core businesses and high-growth opportunities and makes a greater impact for our customers and patients,” BD CEO Tom Polen said.

“As a standalone public company, we believe NewCo will be better positioned to leverage its leadership position in insulin delivery to advance vital, innovative solutions to the large and growing number of people living with diabetes worldwide,” Polen added.

https://www.fiercebiotech.com/medtech/bd-to-spin-off-diabetes-care-business-into-newco-a-standalone-public-company

Healthcare apparel brand FIGS files for a $100 million IPO

 FIGS, a medical scrubs and healthcare apparel brand, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering.


FIGS is a direct-to-consumer healthcare apparel brand that seeks to create technically advanced products that provide comfort, durability, function, and style. The company's medical scrubs use a proprietary fabric, called FIONx, which has four-way stretch, anti-odor, anti-wrinkle, and moisture-wicking properties. The company claims to have branded a previously unbranded industry.

The Santa Monica, CA-based company was founded in 2013 and booked $318 million in sales for the 12 months ended March 31, 2021. It plans to list on the NYSE under the symbol FIGS. Goldman Sachs, Morgan Stanley, Barclays, Credit Suisse and BofA Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Biofrontera prelim April revenue up 400%

Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today reported preliminary, unaudited revenue for the month of April 2021.

The Company’s preliminary, unaudited revenue from product sales in April 2021 amounted to approximately EUR 2,491 thousand, compared to EUR 492 thousand in April 2020, an increase of 406%. Total revenue for the month of April 2020 was EUR 6,602 thousand, whereby April 2020 included a one-time down payment of EUR 6,000 thousand from Maruho Co., Ltd as part of a license and supply agreement.

Preliminary revenues from product sales in the US were around EUR 1,821 thousand compared to EUR 333 thousand in April 2020, an increase of 447%. In Germany, revenues from product sales amounted to approximately EUR 441 thousand, compared to EUR 143 thousand in April 2020, an increase of 208%. In the rest of Europe, the Company generated product sales of around EUR 229 thousand, compared to EUR 17 thousand in April 2020, a plus of 1,247%.

Preliminary unaudited revenues

April

January - April

in EUR thousands

2021

2020

2019

2021

2020

2019

USA

1,821

333

1,767

5.631

4,513

6,939

Germany

441

143

353

1,845

1,453

1,425

Europe (ex Germany)

229

17

191

493

836

755

Total revenue from product sales

2,491

492

2,311

7,969

6,802

9,119

Revenues from R&D projects and license payments

-

6,110

44

-

6,273

44

Total revenue

2,491

6,602

2,355

7,969

13,075

9,163

For better comparability, the Company also included the monthly sales performance before the pandemic in 2019. Compared to 2019, total product sales in 2021 were up 8% in all markets. In detail, April 2021 sales were up 3% in the U.S., 25% in Germany and 20% in the rest of the European markets compared to April 2019.

The sales increase compared to the previous year already perceived since mid-March 2021, especially in our most important sales market, the USA, continued strongly in April 2021. This indicates a significant recovery of the COVID-19 situation in the USA as well as in Germany - presumably also due to the high vaccination rates.

https://finance.yahoo.com/news/biofrontera-reports-preliminary-revenue-month-112300200.html