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7 Blockbuster Drugs Expected To Be Launched In 2020

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Pills falling out of bottle. (Image via Shutterstock)
By Shanthi Rexaline

Biotech stocks had a fairly decent run in 2019, thanks to record deal flow, several path-breaking innovation in drug research & development and the positive broader market sentiment. New molecular entity approvals totaled 48 in 2019, less than the 59 NME approvals in 2018.

The new year is expected to be risk fraught, as lawmakers are expected to step up their rhetoric on drug pricing. Even as the outlook for drug companies remains not-so-promising, some key drug approvals could still impart some momentum to the sector.

The FDA could expedite the review of some drugs, Evaluate Pharma said, citing some approvals in 2019 that came about well ahead of the scheduled PDUFA date such as Vertex Pharmaceuticals Incorporated’s (NASDAQ: VRTX) Trikafta. Trikafta, a treatment option for cystic fibrosis, was approved five months ahead of the PDUFA date.

The following are the drugs with blockbuster potential that could make their way from lab to the shelves, according to Evaluate Pharma.

Trastuzumab deruxtecan

  • Sponsor: Daiichi Sankyo Company, Limited (OTC: DSNKY) & AstraZeneca plc (NYSE: AZN)
  • Indication: Her2 positive breast cancer
  • Status: BLA accepted with priority review status in October and the PDUFA date has been fixed for second quarter of 2020

Palforzia

  • Sponsor: Aimmune Therapeutics Inc (NASDAQ: AIMT)
  • Indication: Peanut allergy
  • Status: PDUFA date of January; A FDA panel, which met in September, voted 7 to 2 that the efficacy data and 8 to 1 that the safety data in conjunction with additional safeguards are adequate to support the use of Palforzia

Ozanimod

  • Sponsor: Bristol-Myers Squibb Co (NYSE: BMY) (came into the company’s stable through its Celgene buy)
  • Indication: relapsing form of multiple sclerosis
  • Status: The FDA accepted for review the BLA in June and has set a PDUFA date of March 25

Inclisiran

  • Sponsor: Novartis AG (NYSE: NVS)(came into the company’s stable through its Medicines Company buy)
  • Indication: LDL-cholesterol lowering therapy
  • Status: NDA submitted in December for use in secondary prevention patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia

Roxadustat

  • Sponsor: AstraZeneca/FibroGen Inc (NASDAQ: FGEN)
  • Indication: treating anemia associated with chronic kidney disease
  • Status: FibroGen, AstraZeneca’s partner in developing roxadustat, said it has submitted the NDA to the FDA in late December

Sacituzumab Govitecan

  • Sponsor: Immunomedics, Inc. (NASDAQ: IMMU)
  • Indication: treating metastatic triple-negative breast cancer
  • Status: After an initial snub, the company resubmitted the BLA and the FDA accepted the application for review Dec. 26, 2019, fixing a PDUFA action date of June 2

Filgotinib

  • Sponsor: Gilead Sciences, Inc. (NASDAQ: GILD) and GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • Indication: rheumatoid arthritis
  • Status: The NDA was submitted Dec. 16, 2019, with the review period expected to be expedited due to a priority review voucher submitted along with the application

biotechnology

Biotechnology: On The Edge of Another Explosion

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Biotechnology: On The Edge of Another Explosion

On the most fundamental level, biotechnology is any technology or product developed using cellular and biomolecular processes. The products as simple as bread and cheese could be considered biotech innovations. Today, the biotech field has expanded substantially, and those involved in it are making significant strides towards solving some of the world’s greatest problems.

Biotech stocks went into one of the greatest abyss in their history which started last summer. However, as they are going down, there are still hope for their recovery.

The three years of running which let it more than quadruples its by value on its highest point last July, IBD’s Medical-Biomed or the Biotech Industry Group surprisingly went down 50% early this February. It was affected by recoils against hike up of drug prices and mergers that are looking for safer with lower taxes.

Despite this downfall, the group has regained 12% since this February 11 low together with some stocks leading better that that as mentioned.

The rise of the stock under Biotech was driven by the first wave of biotech innovation when companies like Amgen and Roche‘s (RHHBY) Genentech proved that biotechnology could produce blockbusters. Vandeventer says that innovation will remain the key to maintaining pricing power, even under political pressure. Despite much political criticism of Sovaldi’s high price, no one could stop it because the drug was superior to anything else on the market.

Signs and indicators that even generalist investors conclude biotech stocks have become cheaper. During the first quarter, a common lament was that every biotech stock got punished for bad news, but this news does not have a bearing at all. But when Biogen issued a mixed earnings report that drew mostly negative reactions from Wall Street on April 21, its stock rose more than 5%.

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How Did Pfizer Grow With Weak Dollar?

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How Did Pfizer Grow With Weak Dollar?
How was Pfizer helped by the weakening of dollar?

Pfizer topped the expectations when the pharmaceuticals giant on the first-quarter revenue went up to $13 billion with adjusted earnings per share of 67 cents. Not only this, Pfizer also shoots with a full-year guidance not only the top but both the top and bottom lines. Today, it is not expected on 2016 revenue to have $52 billion at the midpoint of guidance, up from $50 billion.

What helped this to happen? – The new products such as breast-cancer drug called Ibrance and the vaccine for pneumonia called Prevnar 13 is selling exceeding the anticipation of analysts. On the other hand, greenback’s recent travails also contributed to this help.

According to the Wall Street Journal Dollar Index, the measure of currency’s strength is up more than 25% over the last five years but also 6% down so far this year. The dollar is accounted for the half of Pfizer’s growth in the mid of its guidance.

 

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